AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT— 510(k) K855034

Name: FDA 510(k) clearance K855034
Creator: U.S. Food and Drug Administration
Published: 1986-03-11

Substantially Equivalent

Bartels Immunodiagnostic Supplies, Inc.

FDA 510(k) clearance K855034 for AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT, Substantially Equivalent on 1986-03-11. Applicant: Bartels Immunodiagnostic Supplies, Inc.. Device class: 1.

Clearance details

Applicant: Bartels Immunodiagnostic Supplies, Inc.
Product code: Code LIJ
Device class: Class 1
Regulation: 21 CFR 864.4400
Advisory panel: Pathology
Date received: 1985-12-17
Decision date: 1986-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

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