Cleared Traditional

HEMAGEN ANTI CARDIOLIPIN SCREEN

K971039 · Hemagen Diagnostics, Inc. · Immunology
Jun 1997
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K971039 is an FDA 510(k) clearance for the HEMAGEN ANTI CARDIOLIPIN SCREEN, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Hemagen Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on June 3, 1997, 74 days after receiving the submission on March 21, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K971039 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1997
Decision Date June 03, 1997
Days to Decision 74 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MID — System, Test, Anticardiolipin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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