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510(k) K930305

COBAS CORE PROLACTIN EIA by Roche Diagnostic Systems, Inc. — Product Code CFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1993
Date Received
January 21, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Prolactin (Lactogen)
Device Class
Class I
Regulation Number
862.1625
Review Panel
CH
Submission Type

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  • K983555 — ABUSCREEN ONLINE BENZ 200 CALIBRATORS (December 15, 1998)
  • K983556 — ABUSCREEN ONLINE BENZ 300 CALIBRATORS (December 15, 1998)
  • K983703 — MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE (December 11, 1998)
  • K983697 — MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE (December 11, 1998)
  • K983699 — MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES (December 11, 1998)
  • K983700 — MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (December 11, 1998)
  • K983701 — MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS (December 11, 1998)

Other clearances for product code CFT

  • K971921 — PROLACTIN (PRL) HORMONE MICROPLATE ELISA (June 24, 1997)
  • K970281 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (February 25, 1997)
  • K970188 — SEALITE SCIENCES, INC. AQUALITE PROLACTIN (February 20, 1997)
  • K964748 — ELECSYS PROLACTIN ASSAY (January 21, 1997)
  • K960561 — DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 (April 26, 1996)
  • K960060 — DSL ACTIVE PROLACTIN IRMA (February 29, 1996)
  • K954680 — ACCESS PROLACTIN ASSAY (MODIFICATION) (October 20, 1995)
  • K953656 — ABBOTT IMX PROLACTIN(MODIFICATION) (October 3, 1995)
  • K953657 — ABBOTT AXSYM PROLACTIN(MODIFICATION) (September 25, 1995)
  • K944698 — AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 (March 21, 1995)