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510(k) K811319

CHLORIDE REAGENT KIT by Chem-Elec, Inc. — Product Code JFS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1981
Date Received
May 12, 1981
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

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  • K811165 — GLUCOSE OXIDASE RATE REAGENT (August 13, 1981)
  • K811381 — ASTRA (August 13, 1981)
  • K811406 — CREATININE RATE REAGENT KIT (August 13, 1981)
  • K811193 — BUN RATE REAGENT (July 10, 1981)
  • K811310 — SODIUM/POTASSIUM REAGENT KITS (July 10, 1981)
  • K811701 — CHLORIDE/CARBON DIOXIDE RATE REAGENT (July 1, 1981)

Other clearances for product code JFS

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  • 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)
  • K811701 — CHLORIDE/CARBON DIOXIDE RATE REAGENT (July 1, 1981)
  • K810550 — SILVER ANODE (April 8, 1981)
  • K810615 — CORNING 925 CHLORIDE METER (March 17, 1981)
  • K802080 — BAKER DIAG. ULTRARATE CHLORIDE KIT (October 10, 1980)