Cleared Traditional

THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES

K973203 · Sangstat Medical Corp. · Immunology
Sep 1998
Decision
400d
Days
Class 2
Risk

About This 510(k) Submission

K973203 is an FDA 510(k) clearance for the THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES, a Complement C1q, Antigen, Antiserum, Control (Class II — Special Controls, product code DAK), submitted by Sangstat Medical Corp. (Menlo Park, US). The FDA issued a Cleared decision on September 30, 1998, 400 days after receiving the submission on August 26, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K973203 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 1997
Decision Date September 30, 1998
Days to Decision 400 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DAK — Complement C1q, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240