Cleared Traditional

AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA

K991942 · Cogent Diagnotics , Ltd. · Immunology

Aug 1999

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K991942 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA, a Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control (Class II — Special Controls, product code MLE), submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on August 24, 1999, 76 days after receiving the submission on June 9, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5110.

Submission Details

510(k) Number	K991942 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 1999
Decision Date	August 24, 1999
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	MLE — Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5110