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510(k) K760401

COCAINE KIT, TOXI-PAK by J.T. Baker Chemical Co. — Product Code DLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1976
Date Received
August 6, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

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  • K802035 — BAKER DIAG. ULTRARATE CO2 REAGENT KIT (September 26, 1980)
  • K801662 — J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. (September 16, 1980)
  • K801669 — J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO (September 16, 1980)
  • K801661 — J.T. BAKER CERULOPLASMIN NEPHELOMETRIC (September 16, 1980)
  • K801795 — BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. (September 16, 1980)
  • K801362 — ALBUMIN NEPHELOMETRIC ASSAY (July 21, 1980)
  • K801433 — HAPTOGLOBIN NEPHELOMETRIC ASSAY (July 8, 1980)

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