AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA— 510(k) K993085

Name: FDA 510(k) clearance K993085
Creator: U.S. Food and Drug Administration
Published: 2000-02-01

Substantially Equivalent

Cogent Diagnotics , Ltd.

FDA 510(k) clearance K993085 for AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA, Substantially Equivalent on 2000-02-01. Applicant: Cogent Diagnotics , Ltd.. Device class: 2.

Clearance details

Applicant: Cogent Diagnotics , Ltd.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1999-09-15
Decision date: 2000-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, US

Download summary PDF View on FDA.gov ↗

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