FDA.reportPublic FDA data

Cascade M-4 (110V/220V)

Primary DI
M52517110000
Brand
Cascade M-4 (110V/220V)
Company
HELENA LABORATORIES CORPORATION
Model
1711000
Published
2016-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKPINSTRUMENT, COAGULATION, AUTOMATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKPInstrument, Coagulation, AutomatedHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931956000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931956000CASCADE M, CAT. NO. 1710Helena Laboratories1993-08-23GKP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52517110000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry, electromagnetic and/or mechanical means of clot formation or end point detection.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)231-5663helena@helena.com

Regulatory Flags#

DUNS number
836287433
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M52551830AB-Trol 3 Coagulation Control51832016-08-18
M52551850Coagulation S.A.R.P (Specialty Assayed Reference Plasma)51852016-09-07
M52551860NORM-TROL 1 Coagulation Control51862016-09-07
M52551870AB-TROL 2 Coagulation Control51872016-09-07
M52553010Coagulation S.A.C.-1 (Specialty Assay Control)53012016-09-07
M52553020Coagulation S.A.C.-2 (Specialty Assay Control)53022016-09-07
M52536110H-Pette without Blade (1000 pieces)36112017-05-26
M52536120H-Pette with Blade (1000 pieces)36122017-05-26
M52536130H-Pette Remover36132017-03-17
M52536150H-Pette II (No Blade, Metal Canula) (1000 pieces)36152017-05-26
M52594230IFE Free Lambda Light Chain Antiserum94232024-09-27
M5255527370SPIFE Nexus IFE-6 Antisera Kit5527372024-09-27
M5255527440SPIFE Nexus IFE-9/15 Antisera Kit5527442024-09-27
M52594190IFE IgD Antiserum94192024-09-27
M52594200IFE IgE Antiserum94202024-09-27
M52594220IFE Free Kappa Light Chain Antiserum94222024-09-27
M52520050000ProtoFluor Z (110V)20050002017-03-17
M52520050020ProtoFluor Z (110V)20050022017-03-17
M52520060000ProtoFluor Z (220V)20060002017-03-17
M52518360V8 Urine Preparation Buffer18362023-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00195226000542ACL TOP 770sINSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
00195226000559ACL TOP 570INSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
00195226000566ACL TOP 370INSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
04987562516797CA CAL SSYSMEX CORPORATIONGKP2024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620SYSMEX CORPORATIONGKP2024-02-22
04987562518685Automated Blood Coagulation Analyzer CA-600 series CA-660SYSMEX CORPORATIONGKP2024-02-22
10850044118042iHealthIHEALTH LAB INC.GKP2022-09-30
10850044118059iHealthIHEALTH LAB INC.GKP2022-09-30
08426950452867HemosIL Reference EmulsionINSTRUMENTATION LABORATORY COMPANYGKP2020-04-09
08426950928027ACL TOP 300 CTSINSTRUMENTATION LABORATORY COMPANYGKP2018-05-28
00842768012198Behring Coagulation CupSiemens Healthcare Diagnostics Products GmbHGKP2017-10-31
00842768014444BCS® System Cuvette RotorsSiemens Healthcare Diagnostics Products GmbHGKP2017-10-31
04987562205936CA CAL SSYSMEX CORPORATIONGKP2017-10-06
00842768008023BC Validation KitSiemens Healthcare Diagnostics Products GmbHGKP2016-09-24
00630414945514BCS® XP SystemSiemens Healthcare Diagnostics Products GmbHGKP2016-09-24
08426950003106HemosIL Sample DiluentINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950055990HemosIL Cleaning Solution (Clean A)INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950062295HemosIL Factor DiluentINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950075899Cuvettes (2400 cuvettes)INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497059ACL AcuStar cuvettes (1400 pcs)INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950784074ACL TOP 750INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950784081ACL TOP 350 CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950927990ACL TOP 700INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950451600ACL TOP CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950453499ACL TOP 500 CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497974ACL TOP 700INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497981ACL TOP 700 CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497998ACL TOP 700 LASINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23