MAT (TM) MICROALBUMIN TEST— 510(k) K875161

Name: FDA 510(k) clearance K875161
Creator: U.S. Food and Drug Administration
Published: 1988-02-17

Substantially Equivalent

Wampole Laboratories

FDA 510(k) clearance K875161 for MAT (TM) MICROALBUMIN TEST, Substantially Equivalent on 1988-02-17. Applicant: Wampole Laboratories. Device class: 2.

Clearance details

Applicant: Wampole Laboratories
Product code: Code DCF
Device class: Class 2
Regulation: 21 CFR 866.5040
Advisory panel: Immunology
Date received: 1987-12-15
Decision date: 1988-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

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