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510(k) K771834

CREATININE by Gamma Enterprises, Inc. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1977
Date Received
September 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
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)
  • K780507 — SERUM GLUTAMIC-PYRUVIC TRANSAMINASE (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)
  • K771838 — SERUM IRON (November 3, 1977)
  • K771837 — POTASSIUM (November 2, 1977)

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