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510(k) K873127

CHLORIDE REAGENT KIT by A-Kem, Inc. — Product Code JFS

K873127 is an FDA 510(k) premarket notification submitted by A-Kem, Inc. for the device "CHLORIDE REAGENT KIT". The FDA issued a decision of Substantially Equivalent on October 23, 1987. The device falls under product code JFS (Coulometric, Chloride), a Class II device regulated under 21 CFR 862.1170. A-Kem, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1987
Date Received
August 10, 1987
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 A-Kem, Inc.

  • K884224 — TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS (December 15, 1988)
  • K884226 — AMYLASE REAGENT KIT FOR ASTRA SYSTEMS (December 9, 1988)
  • K884227 — CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM (December 9, 1988)
  • K884225 — TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS (December 9, 1988)
  • K882587 — A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM (August 8, 1988)
  • K882586 — A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM (August 8, 1988)
  • K873126 — SODIUM/POTASSIUM REAGENT KIT (October 23, 1987)
  • K873128 — GLUCOSE REAGENT KIT (October 23, 1987)
  • K873131 — CREATININE REAGENT KIT (October 23, 1987)
  • K873132 — BUN REAGENT KIT (October 23, 1987)

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)
  • 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)
  • K802080 — BAKER DIAG. ULTRARATE CHLORIDE KIT (October 10, 1980)

FDA data resources