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510(k) K914462

SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) by Serono-Baker Diagnostics, Inc. — Product Code JLS

K914462 is an FDA 510(k) premarket notification submitted by Serono-Baker Diagnostics, Inc. for the device "SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)". The FDA issued a decision of Substantially Equivalent on Oct 23, 1991. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Serono-Baker Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 23, 1991
Date Received
Oct 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Progesterone
Device Class
Class I
Regulation Number
862.1620
Review Panel
CH
Submission Type

Other clearances by Serono-Baker Diagnostics, Inc.

  • K924257 — TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY (Nov 30, 1992)
  • K915164 — SRI TESTOSTERONE ENZYME IMMUNOASSAY (Mar 2, 1992)
  • K914886 — SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) (Mar 2, 1992)
  • K915602 — SRI DIGOXIN ENZYME IMMUNOASSAY (Jan 17, 1992)
  • K912937 — SR1 FREE T4 ENZYME IMMUNOASSAY (Nov 19, 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)
  • K910837 — SRI TSH IMMUNENZYMETRIC ASSAY (May 24, 1991)

Other clearances for product code JLS

  • K040923 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA (Jul 22, 2004)
  • K973898 — PROGESTERONE ELISA (Nov 13, 1997)
  • K972133 — VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTE (Jun 24, 1997)
  • K971725 — OPUS PROGESTERONE (Jun 18, 1997)
  • K964841 — ELECSYS PROGESTERONE ASSAY (Mar 24, 1997)
  • K965084 — VIDAS PROESTERONE (PRG) (30 409) (Jan 9, 1997)
  • K955025 — AXSYM PROGESTERONE (Mar 7, 1996)
  • K955769 — ACCESS PROGESTERONE ASSAY (Feb 5, 1996)
  • K952075 — PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM (Jun 13, 1995)
  • K951630 — AURAFLEX PROGESTERONE 150TEST PACK (May 8, 1995)

FDA data resources