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510(k) K923598

REDI-CHECK PHOTMETER Q.A. by Awareness Technology, Inc. — Product Code JFS

K923598 is an FDA 510(k) premarket notification submitted by Awareness Technology, Inc. for the device "REDI-CHECK PHOTMETER Q.A.". The FDA issued a decision of Substantially Equivalent on October 14, 1992. The device falls under product code JFS (Coulometric, Chloride), a Class II device regulated under 21 CFR 862.1170. Awareness Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1992
Date Received
July 20, 1992
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 Awareness Technology, Inc.

  • K171476 — SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) (February 27, 2018)
  • K013420 — CHEMWELL, ALSO KNOWN AS PROJECT 2900 (July 19, 2002)
  • K010877 — CHEMWELL, MODEL 2900 (May 23, 2001)
  • K974762 — STAT TRACKS (January 28, 1998)
  • K943729 — DYE CHECK STRIPS 545-630 (December 29, 1994)
  • K941394 — STAT FAX 2600 (June 3, 1994)
  • K900224 — STAT FAX(TM)-2100 (March 1, 1990)
  • K892656 — DRI-DYE CHECK STRIPS (TM)-405 (May 22, 1989)
  • K882938 — STAT FAX(TM) (September 9, 1988)
  • K873451 — PROJECT 300 MICROASSAY BP-12, EIA MINILAB (November 4, 1987)

Other clearances for product code JFS

  • K121823 — CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLOR (March 27, 2013)
  • 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)
  • K802080 — BAKER DIAG. ULTRARATE CHLORIDE KIT (October 10, 1980)

FDA data resources