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Panels › Clinical Chemistry › Product code CIW · Class 2

Starch-Dye Bound Polymer, Amylase

Regulation 862.1070

0510(k)s in 12 months (8 all time)

0recalls in 12 months (5 all time)

5recalls that name a 510(k)

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Top companies in CIW

Company	510(k)s	Recalls
Ortho-Clinical Diagnostics	0	5
Bio-Analytics Laboratories, Inc.	1	0
Boehringer Mannheim Corp.	1	0
Calbiochem-Behring Corp.	1	0
Data Medical Associates, Inc.	1	0
Eastman Kodak Company	1	0
Em Diagnostic Systems, Inc.	1	0
Olympus Corp.	1	0
Pharmacia, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
May 11, 2020	Ortho-Clinical Diagnostics VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plas Terminated	CIW	K812027
May 11, 2020	Ortho-Clinical Diagnostics VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasm Terminated	CIW	K812027
May 11, 2020	Ortho-Clinical Diagnostics VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase act Terminated	CIW	K812027
May 11, 2020	Ortho-Clinical Diagnostics VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase a Terminated	CIW	K812027
Nov 15, 2013	Ortho-Clinical Diagnostics VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) Terminated	CIW	K812027

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