Home / 510(k) Clearances / K803013

510(k) K803013

CHLORIDE/TCO2 ANALYZER REAGENTS by Laboratory Products, Inc. — Product Code CHJ

K803013 is an FDA 510(k) premarket notification submitted by Laboratory Products, Inc. for the device "CHLORIDE/TCO2 ANALYZER REAGENTS". The FDA issued a decision of Substantially Equivalent on January 2, 1981. The device falls under product code CHJ (Mercuric Thiocyanate, Colorimetry, Chloride), a Class II device regulated under 21 CFR 862.1170. Laboratory Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1981
Date Received
November 28, 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 Laboratory Products, Inc.

  • K832588 — CIN AGAR (September 12, 1983)
  • K803051 — FLAME PHOTOMETRY REAGENTS (January 9, 1981)
  • K803050 — SPRAY, SYNTHETIC SMEAR (December 30, 1980)
  • K800180 — VARIOUS REAGENTS FOR BLOOD CELL ANALYZER (March 19, 1980)
  • K792482 — CHEMISTRY ANALYZER REAGENTS (January 11, 1980)
  • K792481 — CULTURE PLATES & TUBED MEDIA (December 31, 1979)
  • K792483 — STAINS, COUNTERSTAINS & GEN. PURPOSE (December 18, 1979)

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