HEALTH CHECK URI-TEST PROTEIN IN URINE— 510(k) K972960

Name: FDA 510(k) clearance K972960
Creator: U.S. Food and Drug Administration
Published: 1998-10-07

Substantially Equivalent

Tcpi, Inc.

FDA 510(k) clearance K972960 for HEALTH CHECK URI-TEST PROTEIN IN URINE, Substantially Equivalent on 1998-10-07. Applicant: Tcpi, Inc.. Device class: 1.

Clearance details

Applicant: Tcpi, Inc.
Product code: Code JIR
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 1997-08-11
Decision date: 1998-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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