Panels › Clinical Chemistry › Product code JGP · Class 2

Lowry (Colorimetric), Total Protein

Regulation 862.1635

0510(k)s in 12 months (5 all time)

0recalls in 12 months (2 all time)

1recalls that name a 510(k)

Top companies in JGP

Company	510(k)s	Recalls
Ortho-Clinical Diagnostics	0	2
Biovation, Inc.	1	0
J. D. Assoc.	1	0
Johnson & Johnson Clinical Diagnostics, Inc.	1	0
Panmed, Inc.	1	0
Pointe Scientific, Inc.,	1	0

Date	Firm and product	Code	Linked 510(k)
Dec 8, 2016	Ortho-Clinical Diagnostics VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine. Terminated	JGP	K964960
Nov 15, 2013	Ortho-Clinical Diagnostics VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protein (UPRO) concentration in urine using VITROS 250/350/950/5,1 FS Terminated	JGP	None listed

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