PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI— 510(k) K893508

Name: FDA 510(k) clearance K893508
Creator: U.S. Food and Drug Administration
Published: 1989-08-04

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K893508 for PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI, Substantially Equivalent on 1989-08-04. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1989-05-05
Decision date: 1989-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

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