ACE ALT REAGENT— 510(k) K113382

Clearance details

Applicant

Alfa Wassermann

Product code

Code CKA

Device class

Class 1

Regulation

21 CFR 862.1030

Advisory panel

Clinical Chemistry

Date received

2011-11-16

Decision date

2012-07-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

West Caldwell, NJ, US

• K120945 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST2013-06-07
• K061020 — DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE2006-05-10
• K020487 — CARESIDE ALT2002-06-04
• K980028 — ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)1998-02-02
• K973869 — TRACE REAGENT LINE FOR THE COBAS MIRA1998-01-07

• K131515 — ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT2013-08-14
• K113436 — ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT2012-07-12
• K113435 — ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT2012-07-02

• Z-1530-2014 — Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST 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 laboratories.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 K113382.