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510(k) K780507

SERUM GLUTAMIC-PYRUVIC TRANSAMINASE by Gamma Enterprises, Inc. — Product Code CKC

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
Vanillin Pyruvate, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
Review Panel
CH
Submission Type

Other clearances by Gamma Enterprises, Inc.

  • K790578 — GAMMA SMAC REAGENTS (May 15, 1979)
  • K780506 — CARBON DIOXIDE REAGENTS (May 3, 1978)
  • K780504 — CREATINE PHOSPHOKINASE (CPK) (May 3, 1978)
  • K780505 — SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE (May 3, 1978)
  • K771836 — LACTATE DEHYDROGENASE (November 22, 1977)
  • K771843 — WETTING AGENTS (November 22, 1977)
  • K771832 — CHLORIDE (November 22, 1977)
  • K771834 — CREATININE (November 3, 1977)
  • K771838 — SERUM IRON (November 3, 1977)
  • K771837 — POTASSIUM (November 2, 1977)

Other clearances for product code CKC

  • K832791 — SERAYZER ALT/SGPT REAGENT STRIPS (October 14, 1983)