UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE— 510(k) K981573

Name: FDA 510(k) clearance K981573
Creator: U.S. Food and Drug Administration
Published: 1998-09-15

Substantially Equivalent

United Biotech, Inc.

FDA 510(k) clearance K981573 for UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE, Substantially Equivalent on 1998-09-15. Applicant: United Biotech, Inc.. Device class: 2.

Clearance details

Applicant: United Biotech, Inc.
Product code: Code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1998-05-04
Decision date: 1998-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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