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510(k) K780504

CREATINE PHOSPHOKINASE (CPK) by Gamma Enterprises, Inc. — Product Code JHS

K780504 is an FDA 510(k) premarket notification submitted by Gamma Enterprises, Inc. for the device "CREATINE PHOSPHOKINASE (CPK)". The FDA issued a decision of Substantially Equivalent on May 3, 1978. The device falls under product code JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Gamma Enterprises, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1978
Date Received
March 30, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Gamma Enterprises, Inc.

  • K790578 — GAMMA SMAC REAGENTS (May 15, 1979)
  • K780505 — SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE (May 3, 1978)
  • K780506 — CARBON DIOXIDE REAGENTS (May 3, 1978)
  • K780507 — SERUM GLUTAMIC-PYRUVIC TRANSAMINASE (May 3, 1978)
  • K771832 — CHLORIDE (November 22, 1977)
  • K771843 — WETTING AGENTS (November 22, 1977)
  • K771836 — LACTATE DEHYDROGENASE (November 22, 1977)
  • K771834 — CREATININE (November 3, 1977)
  • K771838 — SERUM IRON (November 3, 1977)
  • K771829 — ALKALINE PHOSPHATASE (November 2, 1977)

Other clearances for product code JHS

  • K160570 — Creatine Kinase (May 25, 2016)
  • K102706 — CKMB UDR ASSAY (August 19, 2011)
  • K082226 — S40 CREATINE KINASE (CK) (September 18, 2008)
  • K062128 — THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS (August 21, 2006)
  • K990434 — CARESIDE CKMB (April 19, 1999)
  • K990439 — CARESIDE CK (April 19, 1999)
  • K981495 — IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) (June 10, 1998)
  • K962126 — ACS CKMB II IMMUNOASSAY (June 21, 1996)
  • K952250 — STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIME (July 17, 1995)
  • K945083 — ACCESS CK-MB REAGENTS (November 21, 1994)

FDA data resources