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510(k) K802080

BAKER DIAG. ULTRARATE CHLORIDE KIT by J.T. Baker Chemical Co. — Product Code JFS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
August 28, 1980
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 J.T. Baker Chemical Co.

  • K803128 — SERIES 810 PLATELET ANALYZER (April 3, 1981)
  • K801909 — LSA 290 ASSAY REAGENTS/NEPHELOMETRIC (September 26, 1980)
  • K802035 — BAKER DIAG. ULTRARATE CO2 REAGENT KIT (September 26, 1980)
  • K801669 — J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO (September 16, 1980)
  • K801662 — J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. (September 16, 1980)
  • K801795 — BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. (September 16, 1980)
  • K801661 — J.T. BAKER CERULOPLASMIN NEPHELOMETRIC (September 16, 1980)
  • K801362 — ALBUMIN NEPHELOMETRIC ASSAY (July 21, 1980)
  • K801433 — HAPTOGLOBIN NEPHELOMETRIC ASSAY (July 8, 1980)
  • K801434 — J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS (July 8, 1980)

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)
  • 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)