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510(k) K771832

CHLORIDE by Gamma Enterprises, Inc. — Product Code JFS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1977
Date Received
September 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coulometric, Chloride
Device Class
Class II
Regulation Number
862.1170
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)
  • K780507 — SERUM GLUTAMIC-PYRUVIC TRANSAMINASE (May 3, 1978)
  • K780504 — CREATINE PHOSPHOKINASE (CPK) (May 3, 1978)
  • K780506 — CARBON DIOXIDE REAGENTS (May 3, 1978)
  • K771836 — LACTATE DEHYDROGENASE (November 22, 1977)
  • K771843 — WETTING AGENTS (November 22, 1977)
  • K771834 — CREATININE (November 3, 1977)
  • K771838 — SERUM IRON (November 3, 1977)
  • K771837 — POTASSIUM (November 2, 1977)

Other clearances for product code JFS

  • K121823 — CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLOR (March 27, 2013)
  • K923598 — REDI-CHECK PHOTMETER Q.A. (October 14, 1992)
  • K873127 — CHLORIDE REAGENT KIT (October 23, 1987)
  • K830217 — REAGENTS CORNING CHLORIDE METER FOR (February 18, 1983)
  • K823106 — RERMCO TEST CHLORIDE REAGENT (November 16, 1982)
  • K820411 — LIQUIZYME CHLORIDE REAGENT (March 8, 1982)
  • K811319 — CHLORIDE REAGENT KIT (August 13, 1981)
  • K811701 — CHLORIDE/CARBON DIOXIDE RATE REAGENT (July 1, 1981)
  • K810550 — SILVER ANODE (April 8, 1981)
  • K810615 — CORNING 925 CHLORIDE METER (March 17, 1981)