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Panels › Clinical Toxicology › Product code KLS · Class 2

Enzyme Immunoassay, Theophylline

Regulation 862.3880

0510(k)s in 12 months (71 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
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Top companies in KLS

Company510(k)sRecalls
Syva Co.110
Abbott Laboratories70
Siemens Healthcare Diagnostics, Inc05
E.I. Dupont DE Nemours & Co., Inc.30
Ortho-Clinical Diagnostics, Inc.12
Beckman Instruments, Inc.20
Diagnostic Products Corp.20
Electro-Nucleonics Laboratories, Inc.20
Em Diagnostic Systems, Inc.20
Immunotech Corp.20
DateFirm and productCodeLinked 510(k)
Nov 27, 2017Siemens Healthcare Diagnostics, Inc.
Syva EMIT 2000 Theophylline Product Usage: The Syva Emit 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or pl
Terminated		 KLSK913123
Jul 28, 2016Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA Chemistry Systems. Copi
Terminated		 KLSK913123
Jul 28, 2016Siemens Healthcare Diagnostics, Inc.
Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
Terminated		 KLSK913123
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930 VITROS TRIG Slides quantitatively measure triglyceride (T
Terminated		 KLSK130332
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 1307164 VITROS THEO Slides quantitatively measure theophylline (T
Terminated		 KLSK861367
Dec 11, 2012Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro diagnostic use in the quantitative determination of theophyl
Terminated		 KLSK982680
Nov 20, 2012Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum a
Terminated		 KLSK062024
Aug 21, 2003Beckman Coulter Inc
Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29
Terminated		 KLSK922823

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