PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT— 510(k) K964756

Name: FDA 510(k) clearance K964756
Creator: U.S. Food and Drug Administration
Published: 1997-04-23

Substantially Equivalent

Wano-Tech Corp.

FDA 510(k) clearance K964756 for PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT, Substantially Equivalent on 1997-04-23. Applicant: Wano-Tech Corp.. Device class: 2.

Clearance details

Applicant: Wano-Tech Corp.
Product code: Code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1996-11-27
Decision date: 1997-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belmont, CA, US

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