Cleared Traditional

SAS(TM) MONOCLONAL HCG-SLIDE

K930609 · Sa Scientific, Inc. · Chemistry
Mar 1993
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K930609 is an FDA 510(k) clearance for the SAS(TM) MONOCLONAL HCG-SLIDE, a Agglutination Method, Human Chorionic Gonadotropin (Class II — Special Controls, product code JHJ), submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 29, 1993, 52 days after receiving the submission on February 5, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K930609 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 1993
Decision Date March 29, 1993
Days to Decision 52 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