Atlas FDA

CPK-CS

FDA 510(k) clearance K790357 · decided 1979-04-04

Clearance details

K-number
K790357
Device name
CPK-CS
Applicant
Hoffmann-La Roche, Inc.
Decision
Substantially Equivalent
Date received
1979-02-23
Decision date
1979-04-04
Days to decision
40 days
Clearance type
Traditional
Product code
JHT
Device class
2
Regulation number
862.1215
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST (K022409)Spectral Diagnostics, Inc.2002-09-30
MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI (K991299)Princeton BioMeditech Corp.1999-05-28
CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 (K930359)Helena Laboratories1993-04-12
COULTER CK-MB ISOENZYME REAGENT (K904866)Coulter Electronics, Inc.1990-12-13
DSL CK-MB (DSL #3200) (K904721)Diagnostic Systems Laboratories, Inc.1990-12-13
MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB (K901450)Intl. Immunoassay Laboratories, Inc.1990-05-15
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 (K896170)Helena Laboratories1990-02-16
CREATINE KINASE (CK) ISOENZYME MB (K881168)Data Medical Associates, Inc.1988-11-10
SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM (K874284)Diagnostic Chemicals, Ltd. (Usa)1988-01-21
COULTER DART CK-MB ISOENZYME REAGENT SYSTEM (K872041)Coulter Electronics, Inc.1987-09-16
MICROMI-CK(TM) (K872598)Intl. Immunoassay Laboratories, Inc.1987-08-03
IMACK-MB(TM) (K872592)Intl. Immunoassay Laboratories, Inc.1987-07-31

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CEA-ROCHE TEST KIT (P800063/S004)Hoffmann-La Roche, Inc.1983-10-18
CEA-ROCHE TEST KIT (P800063/S003)Hoffmann-La Roche, Inc.1982-10-21
CEA-ROCHE TEST KIT (P800063/S002)Hoffmann-La Roche, Inc.1982-09-16
CEA-ROCHE TEST KIT (P800063/S001)Hoffmann-La Roche, Inc.1982-03-03