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510(k) K923314

AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY by Serex, Inc. — Product Code JXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1992
Date Received
July 7, 1992
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 Serex, Inc.

  • K921834 — AUTOMATES COMA COCAINE METABOLITE ASSAY (June 15, 1992)
  • K901333 — BETA-2 MICROGLOBULIN EIA (April 2, 1990)
  • K895043 — COMA COCAINE METABOLITE ASSAY (EIA) (November 8, 1989)
  • K890694 — BETA-2 MICROGLOBULIN EIA (March 16, 1989)

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)
  • K921140 — STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA (August 20, 1992)
  • K915785 — STC DIAGNOSTICS BENZOYLECGONINE EIA (March 11, 1992)
  • K913737 — IL TEST(TM) COCAINE (December 3, 1991)