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510(k) K862218

DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT by Diagnostic Products Corp. — Product Code KLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1986
Date Received
June 11, 1986
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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  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • 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

  • K010868 — PSYCHEMEDICS RIA COCAINE ASSAY (November 6, 2001)
  • K913867 — URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) (September 19, 1991)
  • 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)