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510(k) K894175

SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY by Serono-Baker Diagnostics, Inc. — Product Code JHI

K894175 is an FDA 510(k) premarket notification submitted by Serono-Baker Diagnostics, Inc. for the device "SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY". The FDA issued a decision of Substantially Equivalent on Dec 19, 1989. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Serono-Baker Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 19, 1989
Date Received
Jun 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
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 JHI

  • K241919 — Innovita HCG Pregnancy Rapid Combo Test (Aug 2, 2024)
  • K203272 — Alltest Pregnancy Rapid Combo Test Cassette (Jan 31, 2022)
  • K172322 — Atellica IM Total hCG (ThCG) (Mar 29, 2018)
  • K172257 — TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Resu (Dec 22, 2017)
  • K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregn (Feb 24, 2016)
  • K130456 — WUNDER PREGNANCY TEST (Apr 8, 2014)
  • K132834 — FASTEP S10 HCG SERUM/URINE COMBO TEST (Jan 9, 2014)
  • K131166 — SOFIA(R) HCG FIA (Aug 2, 2013)
  • K123844 — CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND H (May 30, 2013)
  • K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (Jul 17, 2012)

FDA data resources