Cleared Traditional

ACCUTEX BETA-HCG TEST

K926112 · J.S. Medical Assoc. · Chemistry
Jul 1993
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K926112 is an FDA 510(k) clearance for the ACCUTEX BETA-HCG TEST, a Agglutination Method, Human Chorionic Gonadotropin (Class II — Special Controls, product code JHJ), submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on July 28, 1993, 237 days after receiving the submission on December 3, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K926112 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1992
Decision Date July 28, 1993
Days to Decision 237 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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