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510(k) K895380

SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY by Serono-Baker Diagnostics, Inc. — Product Code CFT

K895380 is an FDA 510(k) premarket notification submitted by Serono-Baker Diagnostics, Inc. for the device "SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY". The FDA issued a decision of Substantially Equivalent on Oct 17, 1989. The device falls under product code CFT (Radioimmunoassay, Prolactin (Lactogen)), a Class I device regulated under 21 CFR 862.1625. Serono-Baker Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 17, 1989
Date Received
Aug 30, 1989
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 Serono-Baker Diagnostics, Inc.

  • K924257 — TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY (Nov 30, 1992)
  • K914886 — SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) (Mar 2, 1992)
  • K915164 — SRI TESTOSTERONE ENZYME IMMUNOASSAY (Mar 2, 1992)
  • K915602 — SRI DIGOXIN ENZYME IMMUNOASSAY (Jan 17, 1992)
  • K912937 — SR1 FREE T4 ENZYME IMMUNOASSAY (Nov 19, 1991)
  • K914462 — SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) (Oct 23, 1991)
  • K911912 — SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) (Sep 18, 1991)
  • K911217 — SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) (Aug 16, 1991)
  • K912318 — ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) (Jul 25, 1991)
  • K911396 — SR1 ESTRADIOL ENZYME IMMUNOASSAY (May 28, 1991)

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)
  • K964748 — ELECSYS PROLACTIN ASSAY (Jan 21, 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)

FDA data resources