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510(k) K791690

CHOLORDE REAGENT by Hi Chem, Inc. — Product Code JFS

K791690 is an FDA 510(k) premarket notification submitted by Hi Chem, Inc. for the device "CHOLORDE REAGENT". The FDA issued a decision of Substantially Equivalent on September 17, 1979. The device falls under product code JFS (Coulometric, Chloride), a Class II device regulated under 21 CFR 862.1170. Hi Chem, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1979
Date Received
July 31, 1979
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 Hi Chem, Inc.

  • K960084 — HICHEM GLUCOSE/HK REAGENT KIT (April 4, 1996)
  • K951818 — HICHEM ALT REAGENT KIT (May 15, 1995)
  • K943684 — HICHEM ENZYME VERIFIER KIT (October 4, 1994)
  • K941764 — HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 (May 13, 1994)
  • K902673 — HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND (July 17, 1990)
  • K863617 — ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) (October 24, 1986)
  • K862027 — LDP REAGENT CARTRIDGE (NO. 88216) (June 13, 1986)
  • K861893 — GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) (June 5, 1986)
  • K861879 — CK REAGENT CARTRIDGE (PRODUCT NO. 88213) (May 29, 1986)
  • K861284 — AP REAGENT CARTRIDGE (April 28, 1986)

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)

FDA data resources