ClearanceBrief
Panels › Clinical Chemistry › Product code CKD · Class 1

Hydrazone Colorimetry, Alt/Sgpt

Regulation 862.1030

0510(k)s in 12 months (11 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in CKD

Company510(k)sRecalls
Alere San Diego, Inc.01
Anco Medical Reagents & Assoc.10
Boehringer Mannheim Corp.10
Cholestech Corp.10
Electro-Nucleonics, Inc.10
Livonia Diagnostics, Inc.10
Medical Specialties, Inc.10
Omega Medical Electronics10
Ortho Diagnostic Systems, Inc.10
Roche Diagnostic Systems, Inc.10
DateFirm and productCodeLinked 510(k)
Apr 17, 2013Alere San Diego, Inc.
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Terminated		 CKDK032027
K991834
Jul 31, 2004Roche Diagnostics Corp.
Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120.
Terminated		 CKDK870246

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