ADI SYPHILIS RPR LIQUID CONTROLS— 510(k) K980638

Name: FDA 510(k) clearance K980638
Creator: U.S. Food and Drug Administration
Published: 1998-07-06

Substantially Equivalent

Ampcor Diagnostics, Inc.

FDA 510(k) clearance K980638 for ADI SYPHILIS RPR LIQUID CONTROLS, Substantially Equivalent on 1998-07-06. Applicant: Ampcor Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ampcor Diagnostics, Inc.
Product code: Code GMP
Device class: Class 2
Regulation: 21 CFR 866.3820
Advisory panel: Microbiology
Date received: 1998-02-19
Decision date: 1998-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, NJ, US

Download summary PDF View on FDA.gov ↗

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