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510(k) K922921

KING DIAGNOSTICS CHLORIDE REAGENT by King Diagnostics, Inc. — Product Code CHJ

K922921 is an FDA 510(k) premarket notification submitted by King Diagnostics, Inc. for the device "KING DIAGNOSTICS CHLORIDE REAGENT". The FDA issued a decision of Substantially Equivalent on October 5, 1992. The device falls under product code CHJ (Mercuric Thiocyanate, Colorimetry, Chloride), a Class II device regulated under 21 CFR 862.1170. King Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1992
Date Received
June 17, 1992
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 King Diagnostics, Inc.

  • K933329 — KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT (October 22, 1993)
  • K931834 — KING SODIUM/POTASSIUM STANDARD MODIFIED (August 25, 1993)
  • K931773 — HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) (August 16, 1993)
  • K931326 — KING DIAGNOSTICS CK REAGENT (June 15, 1993)
  • K923129 — KING DIAGNOSTICS GLUCOSE (HK) REAGENT (November 2, 1992)
  • K922969 — KING DIAGNOSTICS UREA NITROGEN REAGENT (October 13, 1992)
  • K923927 — KING DIAGNOSTICS MAGNESIUM REAGENT (September 30, 1992)
  • K923091 — KING DIAGNOSTICS GAMMA GT REAGENT (September 9, 1992)
  • K923128 — KING DIAGNOSTICS CHOLESTEROL REAGENT (September 9, 1992)
  • K922964 — KING DIAGNOSTIC TRIGLYCERIDES REAGENT (August 18, 1992)

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)
  • K923610 — OLYMPUS CHLORIDE REAGENT (October 2, 1992)
  • K923036 — URINE CHLORIDE (September 9, 1992)
  • K911297 — CHLORIDE REAGENT (April 16, 1991)
  • K910133 — CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED (February 27, 1991)

FDA data resources