Boule Diagnostics Ab

FDA Filings

This page includes the latest FDA filings for Boule Diagnostics Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004008703
• FEI Number: 3004008703
• Name: BOULE MEDICAL AB
• Owner & Operator: Boule Diagnostics AB
• Contact Address: Domnarvsgatan 4 ; Spanga SE-NOTA SE-163 53 SE
• US Agent:
  • Deborah Herrera
  • CLINICAL DIAGNOSTIC SOLUTIONS INC.
  • 954 5290721
  • debbie.herrera@boule.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Domnarvsgatan 4 ; Spanga Stockholms lan [SE-01], SE-163 53 SE
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 1064130
• FEI Number: 3002684533
• Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Owner & Operator: Boule Diagnostics AB
• Contact Address: Domnarvsgatan 4 ; Spanga SE-NOTA SE-163 53 SE
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1800 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	Device	Date
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	Cell-Dyn Emerald Cleaner	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-350 Quintus 5-Part Stopper	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-293 Quintus 5-Part Stopper	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-205 CDS Rinse Solution	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-204 CDS Rinse Solution	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-074 Enzymatic Cleaner Concentrate	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-073 CDS DETERGENT REAGENT	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-066 CDS DETERGENT REAGENT	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-064 CDS DETERGENT REAGENT	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-063 ENZYMATIC CLEANER CONCENTRATE	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-036 Boule Cleaning Kit	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-032 ENZYMATIC CLEANER	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-029 Ac.T Cleaner and Shutdown Solution	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-013 Enzymatic Cleaner Concentrate	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-002 ENZYMATIC CLEANER	2015-11-17
PPM CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-515 Swelab Alfa Combo Pack	2013-02-13
PPM CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-222 Medonic M-Series DualPack	2013-02-13
PPM CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-028 Ac T Diff Reagent Pack	2013-02-13
PPM CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-009 CDS 5-PD Reagent Set	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	Cell-Dyn Emerald Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-504 Medonic CA 620/530 Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-292 Quintus 5-Part Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-287 CDS Abacus 3 Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-212 Medonic M-Series Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-208 Swelab Alfa Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-202 CDS Hematology Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-201 CDS Hematology Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-133 CDS KX21 Hematology Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-128 HEMATOLOGY DILUENT	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-081 CDS Diluent Sheath	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-069 CDS HEMATOLOGY DILUENT	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-067 CDS HEMATOLOGY DILUENT	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-057 CDS Hematology Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-056 CDS Hematology Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-052 CDS Hematology Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-003 HEMATOLOGY DILUENT	2013-02-13
PMN K993375 | KSA CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-007 CDS-LTX Primer	2011-10-11
PMN K993375 | KSA CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-006 CDS-LTX Control	2011-10-11
PMN K993375 | KRZ CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-007 CDS-LTX Primer	2011-10-11
PMN K993375 | KRZ CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-006 CDS-LTX Control	2011-10-11
PMN K993375 | KRY CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-007 CDS-LTX Primer	2011-10-11
PMN K993375 | KRY CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-006 CDS-LTX Control	2011-10-11
PMN K993375 | KRX CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-007 CDS-LTX Primer	2011-10-11
PMN K993375 | KRX CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-006 CDS-LTX Control	2011-10-11
PMN K083420 | GKZ BOULE MEDICAL AB [Boule Diagnostics AB]	Medonic M-series	2009-07-08
GIO BOULE MEDICAL AB [Boule Diagnostics AB]	Boule, MPA Micro Pipettes Plastic	2008-10-23
GJH CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	STAIN	1999-11-02
GJH CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	RETICULOCYTE	1999-11-02
KIP CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-050 CDS SHEATH REAGENT	1999-04-08

Related Finance Registrations

NCAGE Code	AL26N	BOULE DIAGNOSTICS AB
NCAGE Code	S9766	BOULE DIAGNOSTICS AB
CAGE Code	S9766	BOULE DIAGNOSTICS AB
CAGE Code	EX131	BOULE DIAGNOSTICS AB
CAGE Code	AL26N	BOULE DIAGNOSTICS AB