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510(k) K870740

COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5 by Diagnostic Products Corp. — Product Code KLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1987
Date Received
February 25, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cocaine Metabolite
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

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  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

Other clearances for product code KLN

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  • K913722 — ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE (September 10, 1991)
  • K912756 — ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE (July 26, 1991)
  • K910123 — TARGET COCAINE METABOLITE-V (March 19, 1991)
  • K910122 — TARGET COCAINE METABOLITE-R (March 19, 1991)
  • K910044 — MILENIA COCAINE METABOLITE (February 13, 1991)
  • K905730 — ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) (January 15, 1991)
  • K904995 — ABUSCREEN ONLINE TM FOR COCAINE METABOLITE (November 28, 1990)
  • K880674 — MICROMEDIC CRACKPOT RIA KIT (October 6, 1988)