Clinical Diagnostic Solutions Inc

FDA Filings

This page includes the latest FDA filings for Clinical Diagnostic Solutions Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Clinical Diagnostic Solutions Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1064130
FEI Number3002684533
NameCLINICAL DIAGNOSTIC SOLUTIONS, INC.
Owner & OperatorBoule Diagnostics AB
Contact AddressDomnarvsgatan 4
Spanga SE-NOTA SE-163 53 SE
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1800 N.W. 65TH AVE.
PLANTATION, FL 33313 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Albumin Reagent 501-3972020-03-31
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Triglycerides Reagent 501-4172020-03-31
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
CDS-LTX PRIMER 502-0072018-07-06
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
CDS-LTX CONTROL 502-0062018-07-06
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Carbon Dioxide Reagent 501-4072018-06-11
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Urea Nitrogen Reagent Set 501-4042018-04-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
HbA1c Calibrator Set 502-1892018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Multi-Analyte Lipid Control Set 502-1602018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
TIBC Calibrator Set 502-1572018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
HbA1c Control Set 502-1562018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
CRP Control Set 502-1552018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
CRP Calibrator Set 502-1542018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Chemistry Control Level II Set 502-1532018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Chemistry Control Level I Set 502-1522018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Chemistry Calibrator Set 502-1512018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Direct TIBC Reagent Set 501-4442018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
CRP Reagent Set 501-4352018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
HbA1c Reagent Set 501-4212018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
LDL Cholesterol Reagent Set 501-4202018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
HDL Cholesterol Reagent Set 501-4192018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Uric Acid Reagent 501-4182018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Total Protein Reagent 501-4162018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Phosphorus Reagent 501-4152018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Magnesium Reagent Set 501-4142018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
LDH Reagent Set 501-4132018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Iron Reagent Set 501-4122018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Glucose Reagent 501-4112018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
GGT Reagent Set 501-4102018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Creatinine Reagent Set 501-4092018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
CK-NAC Reagent Set 501-4082018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Cholesterol Reagent 501-4062018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Calcium Arsenazo III Reagent 501-4052018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Total Bilirubin Reagent Set 501-4032018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Direct Bilirubin Reagent Set 501-4022018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
AST (SGOT) Reagent Set 501-4012018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
AMYLASE (CNPG3) Reagent Set 501-4002018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
ALT (SGPT) Reagent Set 501-3992018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Alkaline Phosphatase Reagent Set 501-3982018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Boule Con-Diff Tri-Level 501-6082018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
CDS Hematology Calibrator 502-0682018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
CDS 3PD Hematology Control 502-0662018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
CDS Hematology Calibrator 502-0402018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
CDS™ 3-PD Hematology Control 502-0042018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Boule Con-Diff Tri-Level 501-6072018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Boule Cal 501-6062018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Boule Con-Diff Tri-Level 501-6052018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Albumin Reagent 501-3972018-03-29
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
Cell-Dyn Emerald Cleaner2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-350 Quintus 5-Part Stopper2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-293 Quintus 5-Part Stopper2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-205 CDS Rinse Solution2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-204 CDS Rinse Solution2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-074 Enzymatic Cleaner Concentrate2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-073 CDS DETERGENT REAGENT2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-066 CDS DETERGENT REAGENT2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-064 CDS DETERGENT REAGENT2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-063 ENZYMATIC CLEANER CONCENTRATE2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-036 Boule Cleaning Kit2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-032 ENZYMATIC CLEANER2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-029 Ac.T Cleaner and Shutdown Solution2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-013 Enzymatic Cleaner Concentrate2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-002 ENZYMATIC CLEANER2015-11-17
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-515 Swelab Alfa Combo Pack2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-222 Medonic M-Series DualPack2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-028 Ac T Diff Reagent Pack2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-009 CDS 5-PD Reagent Set2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
Cell-Dyn Emerald Diluent2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-504 Medonic CA 620/530 Diluent2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-292 Quintus 5-Part Diluent2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-287 CDS Abacus 3 Diluent2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-212 Medonic M-Series Diluent2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-208 Swelab Alfa Diluent2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-202 CDS Hematology Diluent2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-201 CDS Hematology Diluent2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-133 CDS KX21 Hematology Diluent2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-128 HEMATOLOGY DILUENT2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-081 CDS Diluent Sheath2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-069 CDS HEMATOLOGY DILUENT2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-067 CDS HEMATOLOGY DILUENT2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-057 CDS Hematology Diluent2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-056 CDS Hematology Diluent2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-052 CDS Hematology Diluent2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-003 HEMATOLOGY DILUENT2013-02-13
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
502-007 CDS-LTX Primer2011-10-11
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
502-006 CDS-LTX Control2011-10-11
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
502-007 CDS-LTX Primer2011-10-11
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
502-006 CDS-LTX Control2011-10-11
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
502-007 CDS-LTX Primer2011-10-11
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
502-006 CDS-LTX Control2011-10-11
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
502-007 CDS-LTX Primer2011-10-11
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
502-006 CDS-LTX Control2011-10-11
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
CDS HEMATOLOGY CALIBRATOR (CDS CAL)2004-06-10
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
CDS 3-PD HEMATOLOGY CONTROLS2003-01-14
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER1999-12-20
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
STAIN1999-11-02
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
RETICULOCYTE1999-11-02
CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]
501-050 CDS SHEATH REAGENT1999-04-08

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020052314878Anvers,Belgium -> Charleston, South CarolinaBOTTLE, CLEANING KIT4 PKG
2020041717913Shanghai ,China (Mainland) -> Los Angeles, CaliforniaDODECYLTRIMETHYLAMMONIUM CHLORIDE13 DRM
2020041142982Shanghai ,China (Mainland) -> Los Angeles, CaliforniaDODECYLTRIMETHYLAMMONIUM CHLORIDE13 DRM
2019121237239Shanghai ,China (Mainland) -> Los Angeles, CaliforniaDODECYLTRIMETHYLAMMONIUM CHLORIDE5 DRM
2019112346155Stadersand,Federal Republic of Germany -> Charleston, South CarolinaCLEANING KIT3 PKG
2019060331575Anvers,Belgium -> Charleston, South CarolinaCLEANING KIT4 PKG
2019031833171Shanghai ,China (Mainland) -> Los Angeles, CaliforniaDODECYLTRIMETHYLAMMONIUM CHLORIDE20 DRM
2018111644127Shanghai ,China (Mainland) -> Los Angeles, CaliforniaDODECYLTRIMETHYLAMMONIUM CHLORIDE10 DRM

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