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Panels › Clinical Toxicology › Product code DIH · Class 1

Colorimetry, Cholinesterase

Regulation 862.3240

0510(k)s in 12 months (26 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
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Top companies in DIH

Company510(k)sRecalls
Ortho-Clinical Diagnostics05
Sclavo, Inc.30
Eastman Kodak Company20
Sigma Diagnostics, Inc.20
Bayer Corp.10
Bayer Diagnostics Corp.10
Beckman10
Beckman Coulter, Inc.10
Careside, Inc.10
Crestat Diagnostics, Inc.10
DateFirm and productCodeLinked 510(k)
Jul 17, 2025Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
Open, Classified		 DIHNone listed
Jul 17, 2025Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
Open, Classified		 DIHNone listed
Jul 17, 2025Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products
Open, Classified		 DIHNone listed
Jul 17, 2025Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemist
Open, Classified		 DIHNone listed
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 8004707 VITROS CHE Slides quantitatively measure cholinesterase (C
Terminated		 DIHNone listed

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