Panels › Clinical Toxicology › Product code LDP · Class 2
Colorimetry, Acetaminophen
Regulation 862.3030
1510(k)s in 12 months (37 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
Top companies in LDP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2018 | Roche Diagnostics Corporation Roche Acetaminophen assay
03255379160-HAcetaminophen (P)
20767174160- cobas c Integra AAcetaminophen150 test Terminated |
LDP | K110726 |
| Jul 20, 2017 | Beckman Coulter Inc. Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. U Terminated |
LDP | K081938 |
| Jan 22, 2016 | Sekisui Diagnostics P.E.I. Inc. Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic
Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml
Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml
In-Vitro quant Terminated |
LDP | K081938 |
| Aug 19, 2015 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems. Terminated |
LDP | K100200 |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274
VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma using Terminated |
LDP | K954933 |
| Sep 26, 2012 | Alere San Diego, Inc. Alere Triage TOX Drug Screen 9 Panel, P/N: 94402.
The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of Terminated |
LDP | K043242 K060791 |
| Jun 27, 2012 | Sekisui Diagnostics Llc MULTIGENT Acetaminophen for use with Architect/Aeroset
Cat. No. 2K99-20.
Assay is intended for the quantitative determination of acetaminophen in human serum or plasma. Terminated |
LDP | K042330 |
| Mar 16, 2011 | Roche Diagnostics Operations, Inc. Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number 20767174322, Roche Diagnostics Corporation, Indianapolis, IN.
For the quantitative determinations of toxic levels of ac Terminated |
LDP | K991598 |
| Mar 16, 2011 | Roche Diagnostics Operations, Inc. Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics Corporation, Indianapolis, IN.
For the quantitative determinations of toxic levels of acetaminoph Terminated |
LDP | K013757 |
| Sep 25, 2008 | Beckman Coulter Inc Synchron Acetaminophen (ACTM) Reagent, Part Number 472169.
ACTM Reagent when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 Systems and SYNCHRON Systems Drug Calibrator 2 set, is Terminated |
LDP | K000494 |
| Sep 18, 2007 | Abbott Laboratories Inc. MULTIGENT Acetaminophen, List Number 2K99-20 Terminated |
LDP | K042330 |
| Jul 20, 2004 | Beckman Coulter Inc Synchron Systems Acetaminophen Reagent, part No. 472169. Terminated |
LDP | None listed |
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