Cleared Traditional

CLEARVIEW HCG

K910946 · Unipath , Ltd. · Chemistry
Apr 1991
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K910946 is an FDA 510(k) clearance for the CLEARVIEW HCG, a Agglutination Method, Human Chorionic Gonadotropin (Class II — Special Controls, product code JHJ), submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on April 1, 1991, 26 days after receiving the submission on March 6, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K910946 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 1991
Decision Date April 01, 1991
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHJ — Agglutination Method, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

Similar Devices — JHJ Agglutination Method, Human Chorionic Gonadotropin

All 95
PREGNACOL PREGNANCY TEST
K972606 · Immunostics Inc., · Aug 1997
IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
K921968 · Tech-Co, Inc. · Jun 1996
SAS(TM) DIRECT MONOCLONAL HCG
K935863 · Sa Scientific, Inc. · Feb 1994
ACCUTEX BETA-HCG TEST
K926112 · J.S. Medical Assoc. · Jul 1993
SAS(TM) MONOCLONAL HCG-SLIDE
K930609 · Sa Scientific, Inc. · Mar 1993
DIRECT PREGNANCY TEST
K920716 · Tech-Co, Inc. · Mar 1992