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510(k) K915785

STC DIAGNOSTICS BENZOYLECGONINE EIA by Solarcare Technologies Corp,Inc. — Product Code JXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1992
Date Received
December 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cocaine
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

Other clearances by Solarcare Technologies Corp,Inc.

  • K954326 — STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY (July 23, 1996)
  • K954156 — STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY (July 22, 1996)
  • K955905 — STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY (May 30, 1996)
  • K954158 — STC DIAGNOSTICS AUTO-LYTE PH ASSAY (April 30, 1996)
  • K940048 — STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION (March 19, 1996)
  • K954073 — STC DIAGNOSTICS LSD MICRO-PLATE EIA (November 29, 1995)
  • K954266 — STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY (October 13, 1995)
  • K935573 — AMPHETAMINES MICRO-PLATE EIA (July 14, 1995)
  • K935565 — OPIATES MICRO-PLATE ASSAY (July 14, 1995)
  • K950308 — STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA (April 14, 1995)

Other clearances for product code JXO

  • K201228 — Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair (June 25, 2021)
  • K111925 — PSYCHEMEDICS COCAINE EIA (May 1, 2012)
  • K923314 — AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY (August 24, 1992)
  • K921140 — STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA (August 20, 1992)
  • K913737 — IL TEST(TM) COCAINE (December 3, 1991)