ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT— 510(k) K131351

Name: FDA 510(k) clearance K131351
Creator: U.S. Food and Drug Administration
Published: 2013-08-15

Substantially Equivalent

Alfa Wassermann Diagnostic Technologies, LLC

FDA 510(k) clearance K131351 for ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT, Substantially Equivalent on 2013-08-15. Applicant: Alfa Wassermann Diagnostic Technologies, LLC. Device class: 2.

Clearance details

Applicant: Alfa Wassermann Diagnostic Technologies, LLC
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2013-05-10
Decision date: 2013-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K131351

K-number listed on FDA's recall record

Z-1529-2014 — Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs.Class II·Terminated·Alfa Wassermann, Inc.·20140305

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131351.

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