Cleared Traditional

RAICHEM PREALBUMIN SPIA

K972812 · Hemagen Diagnostics, Inc. · Immunology

Aug 1997

Decision

31d

Days

Class 1

Risk

About This 510(k) Submission

K972812 is an FDA 510(k) clearance for the RAICHEM PREALBUMIN SPIA, a Prealbumin, Fitc, Antigen, Antiserum, Control (Class I — General Controls, product code DDS), submitted by Hemagen Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on August 28, 1997, 31 days after receiving the submission on July 28, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5060.

Submission Details

510(k) Number	K972812 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 1997
Decision Date	August 28, 1997
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF