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510(k) K964748

ELECSYS PROLACTIN ASSAY by Boehringer Mannheim Corp. — Product Code CFT

K964748 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "ELECSYS PROLACTIN ASSAY". The FDA issued a decision of Substantially Equivalent on Jan 21, 1997. The device falls under product code CFT (Radioimmunoassay, Prolactin (Lactogen)), a Class I device regulated under 21 CFR 862.1625. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 21, 1997
Date Received
Nov 26, 1996
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

Other clearances by Boehringer Mannheim Corp.

  • K984326 — ELECYS IGE ASSAY (Feb 8, 1999)
  • K983047 — ACCU-CHEK HQ SYSTEM (Feb 5, 1999)
  • K984419 — ELECSYS IGE CALCHECK (Feb 2, 1999)
  • K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR (Jan 20, 1999)
  • K984372 — ELECSYS CALCHECK TROPONIN T (Dec 14, 1998)
  • K984105 — ELECSYS TROPONIN T STAT TEST (Dec 8, 1998)
  • K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT (Dec 1, 1998)
  • K983469 — PRECISET SERUM PROTEINS CALIBRATOR (Nov 25, 1998)
  • K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (Nov 12, 1998)
  • K982949 — ELECSYS PSA, MODEL 2010 (Oct 27, 1998)

Other clearances for product code CFT

  • K971921 — PROLACTIN (PRL) HORMONE MICROPLATE ELISA (Jun 24, 1997)
  • K970281 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (Feb 25, 1997)
  • K970188 — SEALITE SCIENCES, INC. AQUALITE PROLACTIN (Feb 20, 1997)
  • K960561 — DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 (Apr 26, 1996)
  • K960060 — DSL ACTIVE PROLACTIN IRMA (Feb 29, 1996)
  • K954680 — ACCESS PROLACTIN ASSAY (MODIFICATION) (Oct 20, 1995)
  • K953656 — ABBOTT IMX PROLACTIN(MODIFICATION) (Oct 3, 1995)
  • K953657 — ABBOTT AXSYM PROLACTIN(MODIFICATION) (Sep 25, 1995)
  • K944698 — AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 (Mar 21, 1995)
  • K943811 — ENZYME-LINKED FLUORESCENT IMMUNOASSAY (Nov 2, 1994)

FDA data resources