MILES AUTO METH DETERMIN OF URIC ACID IN URINE— 510(k) K924129

Name: FDA 510(k) clearance K924129
Creator: U.S. Food and Drug Administration
Published: 1992-09-22

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K924129 for MILES AUTO METH DETERMIN OF URIC ACID IN URINE, Substantially Equivalent on 1992-09-22. Applicant: Heraeus Kulzer, Inc.. Device class: 1.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code KNK
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1992-08-17
Decision date: 1992-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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