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510(k) K760394

REAGENT, CHLORIDOMETER ACID by Bulcher Instruments — Product Code JFS

K760394 is an FDA 510(k) premarket notification submitted by Bulcher Instruments for the device "REAGENT, CHLORIDOMETER ACID". The FDA issued a decision of Substantially Equivalent on November 1, 1976. The device falls under product code JFS (Coulometric, Chloride), a Class II device regulated under 21 CFR 862.1170.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1976
Date Received
August 6, 1976
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 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