Cleared Traditional

SAS(TM) DIRECT MONOCLONAL HCG

K935863 · Sa Scientific, Inc. · Chemistry
Feb 1994
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K935863 is an FDA 510(k) clearance for the SAS(TM) DIRECT MONOCLONAL HCG, 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 February 24, 1994, 83 days after receiving the submission on December 3, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K935863 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1993
Decision Date February 24, 1994
Days to Decision 83 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