ClearanceBrief
Panels › Clinical Chemistry › Product code JJE · Class 1

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Regulation 862.2160

0510(k)s in 12 months (208 all time)
10recalls in 12 months (564 all time)
494recalls that name a 510(k)
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Top companies in JJE

Company510(k)sRecalls
Beckman Coulter, Inc.1146
Ortho-Clinical Diagnostics, Inc.1130
Siemens Healthcare Diagnostics288
Abbott Laboratories1357
Roche Diagnostics Corp.042
Roche Diagnostics Operations, Inc.028
Eastman Kodak Company180
Boehringer Mannheim Corp.160
Abbott Gmbh & Co. KG014
Beckman Instruments, Inc.90
Decided510(k)Device and applicantCode
Mar 22, 1978K780388ANALYZER, 100, BICHROMATIC, ABBOTT
Syva Co.
JJE
Mar 9, 1978K780083ANALYZER, SELECTIVE, ELECTRONIC
Johns Scientific, Inc.
JJE
Jan 31, 1978K772344DATA ACQUISITION & COLLATING SYS.
Gilford Instrument Laboratories, Inc.
JJE
Jan 12, 1978K772319ANALYZER, CLINICAL, SYSTEM 3
Gilford Instrument Laboratories, Inc.
JJE
Oct 7, 1977K771245MODEL 2/2 ANALYZER
Eastman Kodak Company
JJE
Aug 4, 1977K771345BICHROMATIC ANALYZER ABA-200
Abbott Laboratories
JJE
May 3, 1977K770679CHEMISTRY, COULTER
Coulter Electronics, Inc.
JJE
Dec 9, 1976K760642ANALYZER, PROGRAMMABLE DISCRETE (PDA)
Anatronics Corp.
JJE

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