TARGET MICROALBUMINURIA TEST— 510(k) K912246

Name: FDA 510(k) clearance K912246
Creator: U.S. Food and Drug Administration
Published: 1991-07-19

Substantially Equivalent

Texas Immunology, Inc.

FDA 510(k) clearance K912246 for TARGET MICROALBUMINURIA TEST, Substantially Equivalent on 1991-07-19. Applicant: Texas Immunology, Inc.. Device class: 1.

Clearance details

Applicant: Texas Immunology, Inc.
Product code: Code JIR
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 1991-05-21
Decision date: 1991-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyler, TX, US

Download summary PDF View on FDA.gov ↗

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