Cleared Traditional

ADI SYPHILIS RPR LIQUID CONTROLS

K980638 · Ampcor Diagnostics, Inc. · Microbiology

Jul 1998

Decision

137d

Days

Class 2

Risk

About This 510(k) Submission

K980638 is an FDA 510(k) clearance for the ADI SYPHILIS RPR LIQUID CONTROLS, a Antisera, Control For Nontreponemal Tests (Class II — Special Controls, product code GMP), submitted by Ampcor Diagnostics, Inc. (Bridgeport, US). The FDA issued a Cleared decision on July 6, 1998, 137 days after receiving the submission on February 19, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3820.

Submission Details

510(k) Number	K980638 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 1998
Decision Date	July 06, 1998
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement