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Panels › Clinical Chemistry › Product code JHW · Class 2

U.V. Method, Cpk Isoenzymes

Regulation 862.1215

0510(k)s in 12 months (27 all time)

0recalls in 12 months (2 all time)

2recalls that name a 510(k)

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Top companies in JHW

Company	510(k)s	Recalls
Intl. Immunoassay Laboratories, Inc.	5	0
Harleco	3	0
Abbott Laboratories	2	0
Biochemical Trade, Inc.	2	0
Elitechgroup	2	0
Roche Diagnostics	2	0
Boehringer Mannheim Corp.	1	0
Diagnostic Systems Laboratories, Inc.	1	0
The Dow Chemical Co.	1	0
Electrophoresis Corp. of America	1	0

Date	Firm and product	Code	Linked 510(k)
Dec 12, 2017	Zimmer Biomet, Inc. PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyart Terminated	JHW	K122765
Jun 29, 2017	Medtest Holdings, Inc. The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit Terminated	JHW	K942958

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