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510(k) K800683

REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM by Diagnostic Solutions, Inc. — Product Code CHJ

K800683 is an FDA 510(k) premarket notification submitted by Diagnostic Solutions, Inc. for the device "REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM". The FDA issued a decision of Substantially Equivalent on May 28, 1980. The device falls under product code CHJ (Mercuric Thiocyanate, Colorimetry, Chloride), a Class II device regulated under 21 CFR 862.1170. Diagnostic Solutions, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1980
Date Received
March 26, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mercuric Thiocyanate, Colorimetry, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type

Other clearances by Diagnostic Solutions, Inc.

  • K934892 — RELIEF PLUS ONE REAGENT STRIP MODIFICATION (January 11, 1994)
  • K924398 — UNI-CHECK REAGENT STRIP (December 23, 1992)
  • K921825 — QUICK-CHECK II REAGENT STRIP (August 18, 1992)
  • K800689 — REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- (May 30, 1980)
  • K800681 — REAGENTS FOR DETERM. CO2 IN HUMAN SERUM (May 30, 1980)
  • K800677 — REAGENTS FOR DETERM. SERUM IRON IN HUMAN (May 28, 1980)
  • K800675 — REAGENTS FOR DETERM. TOTAL BILIRUBIN (May 28, 1980)
  • K800672 — SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC (May 28, 1980)
  • K800674 — SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER (May 28, 1980)
  • K800678 — REAGENTS FOR DETERM. ALBUMIN IN HUMAN (May 28, 1980)

Other clearances for product code CHJ

  • K010670 — PICCOLO CHLORIDE TEST SYSTEM (April 26, 2001)
  • K945408 — 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER (February 22, 1995)
  • K943006 — CHLORIDE QVET (December 7, 1994)
  • K934136 — OLYMPUS CHLORIDE REAGENT, MODIFICATION (November 5, 1993)
  • K932528 — OLYMPUS CHLORID REAGENT, MODIFIED (September 17, 1993)
  • K925338 — OLYMPUS CHLORIDE REAGENT (December 11, 1992)
  • K922921 — KING DIAGNOSTICS CHLORIDE REAGENT (October 5, 1992)
  • K923610 — OLYMPUS CHLORIDE REAGENT (October 2, 1992)
  • K923036 — URINE CHLORIDE (September 9, 1992)
  • K911297 — CHLORIDE REAGENT (April 16, 1991)

FDA data resources