PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT— 510(k) K811169

Name: FDA 510(k) clearance K811169
Creator: U.S. Food and Drug Administration
Published: 1981-05-15

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K811169 for PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT, Substantially Equivalent on 1981-05-15. Applicant: Amersham Corp.. Device class: 2.

Clearance details

Applicant: Amersham Corp.
Product code: Code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1981-04-28
Decision date: 1981-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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