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Panels › Clinical Chemistry › Product code JIX · Class 2

Calibrator, Multi-Analyte Mixture

Regulation 862.1150

0510(k)s in 12 months (302 all time)
1recalls in 12 months (73 all time)
60recalls that name a 510(k)
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Top companies in JIX

Company510(k)sRecalls
Siemens Healthcare Diagnostics1220
Alko Diagnostic Corp.210
Dade Behring, Inc.180
Roche Diagnostics142
Ortho-Clinical Diagnostics, Inc.411
Randox Laboratories, Ltd.510
Bhp Diagnostix, Inc.110
Roche Diagnostic Systems, Inc.90
Beckman Instruments, Inc.80
Boehringer Mannheim Corp.80
Decided510(k)Device and applicantCode
Feb 11, 1977K770142SMA REFERENCE SERUM 3
Technicon Instruments Corp.
JIX
Dec 30, 1976K761309OB-GYN CONTROL SERA (CODE 196300)
Amersham Corp.
JIX

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