ClearanceBrief
Panels › Clinical Chemistry › Product code JIT · Class 2

Calibrator, Secondary

Regulation 862.1150

0510(k)s in 12 months (245 all time)
1recalls in 12 months (55 all time)
40recalls that name a 510(k)
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Top companies in JIT

Company510(k)sRecalls
Dade Behring, Inc.290
Siemens Healthcare Diagnostics1117
Roche Diagnostics180
Abbott Laboratories610
Wako Chemicals USA, Inc.151
Beckman Coulter, Inc.84
Ortho Clinical Diagnostics48
E.I. Dupont DE Nemours & Co., Inc.100
Diamond Diagnostics, Inc.90
Tosoh Bioscience, Inc.53
DateFirm and productCodeLinked 510(k)
May 10, 2011Beckman Coulter Inc.
Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic.
Terminated		 JITK042651
Jul 12, 2007Wako Chemicals USA, Inc.
NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***For in vitro diagnostic use ***Distributed by: Wako Chemicals, USA, Inc. 1600 Bel
Terminated		 JITNone listed
Jan 25, 2007Bio-Rad Laboratories Inc
Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes
Terminated		 JITK041444
Oct 12, 2006Abbott Diagnostic International, Ltd.
Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Terminated		 JITK032458
Oct 12, 2006Abbott Diagnostic International, Ltd.
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Terminated		 JITK032458

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