BUN, MODEL BU 104-01— 510(k) K990980

Substantially Equivalent

A.P. Total Care, Inc.

FDA 510(k) clearance K990980 for BUN, MODEL BU 104-01, Substantially Equivalent on 1999-05-25. Applicant: A.P. Total Care, Inc.. Device class: 2.

Clearance details

Applicant: A.P. Total Care, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1999-03-23
Decision date: 1999-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, CT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.