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510(k) K790357

CPK-CS by Hoffmann-La Roche, Inc. — Product Code JHT

K790357 is an FDA 510(k) premarket notification submitted by Hoffmann-La Roche, Inc. for the device "CPK-CS". The FDA issued a decision of Substantially Equivalent on April 4, 1979. The device falls under product code JHT (Chromatographic Separation, Cpk Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Hoffmann-La Roche, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1979
Date Received
February 23, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic Separation, Cpk Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Hoffmann-La Roche, Inc.

  • K850727 — BHCG-ROCHE EIA (June 25, 1985)
  • K831694 — RENAK (July 19, 1983)
  • K830482 — ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (March 24, 1983)
  • K830481 — ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (March 24, 1983)
  • K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (March 24, 1983)
  • K830461 — ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (March 24, 1983)
  • K830462 — ABUSCREEN RADIOUMMUNOASSAY--URINE (March 24, 1983)
  • K830480 — ABUSCREEN RADIOIMMUNOASSAY-COCAINE META (March 24, 1983)
  • K830479 — ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE (March 10, 1983)
  • K823580 — COBAS REAGENT FOR INORGANIC PHOSPHORUS (January 7, 1983)

Other clearances for product code JHT

  • K022409 — SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST (September 30, 2002)
  • K991299 — MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI (May 28, 1999)
  • K930359 — CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 (April 12, 1993)
  • K904721 — DSL CK-MB (DSL #3200) (December 13, 1990)
  • K904866 — COULTER CK-MB ISOENZYME REAGENT (December 13, 1990)
  • K901450 — MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB (May 15, 1990)
  • K896170 — REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 (February 16, 1990)
  • K881168 — CREATINE KINASE (CK) ISOENZYME MB (November 10, 1988)
  • K874284 — SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM (January 21, 1988)
  • K872041 — COULTER DART CK-MB ISOENZYME REAGENT SYSTEM (September 16, 1987)

FDA data resources