Cleared Traditional

AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA

K991890 · Cogent Diagnotics , Ltd. · Immunology
Aug 1999
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K991890 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA, a Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) (Class II — Special Controls, product code MVJ), submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on August 9, 1999, 67 days after receiving the submission on June 3, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K991890 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1999
Decision Date August 09, 1999
Days to Decision 67 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MVJ — Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660