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510(k) K934775

STC COCAINE METABOLITE EIA by Solarcare, Inc. — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1995
Date Received
October 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Solarcare, Inc.

  • K944372 — STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA (February 8, 1995)
  • K941496 — SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY (October 27, 1994)
  • K941497 — SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY (May 24, 1994)
  • K934376 — STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA (December 7, 1993)
  • K933327 — HISTOFREEZER (October 29, 1993)

Other clearances for product code DIO

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  • K211973 — DRI Cocaine Metabolite Assay (September 24, 2021)
  • K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay (March 12, 2020)
  • K181499 — DRI Cocaine Metabolite Assay (July 6, 2018)
  • K170293 — Emit II Plus Cocaine Metabolite Assay (October 25, 2017)
  • K163570 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) (August 15, 2017)
  • K162395 — MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup (June 2, 2017)
  • K152232 — Quest Diagnostics HairCheck-DT (Cocaine) (November 18, 2016)
  • K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test (June 27, 2016)
  • K153646 — SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Tes (March 18, 2016)