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)
12recalls in 12 months (564 all time)
494recalls that name a 510(k)
Top companies in JJE
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 31, 1993 | K931744 | OLYMPUS REPLY GLUCOSE REAGENT Olympus Corp. | JJE |
| May 12, 1993 | K930489 | AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS E.I. Dupont DE Nemours & Co., Inc. | JJE |
| Feb 12, 1993 | K926060 | SYNCHRON CX5CE CLINICAL ANALYZER Beckman Instruments, Inc. | JJE |
| Feb 12, 1993 | K923579 | MINIVIDAS INSTRUMENT Biomerieux Vitek, Inc. | JJE |
| Sep 29, 1992 | K924084 | ATAC 6000 CHEMISTRY ANALYZER Bio-Chem Laboratory Systems, Inc. | JJE |
| Sep 15, 1992 | K923060 | IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY Becton Dickinson Advanced Diagnostics | JJE |
| Aug 20, 1992 | K922680 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT E.I. Dupont DE Nemours & Co., Inc. | JJE |
| Jul 21, 1992 | K922139 | VISTA IMMUNOASSAY SYSTEM -- MODIFICATION Syva Co. | JJE |
| Jul 10, 1992 | K922072 | KODAK EKTACHEM 250 ANALYER Eastman Kodak Company | JJE |
| Jun 30, 1992 | K921661 | BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER Boehringer Mannheim Corp. | JJE |
| Jun 25, 1992 | K922220 | OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER Olympus Corp. | JJE |
| Apr 29, 1992 | K920402 | ROCHE COBAS MIRA PLUS Roche Diagnostic Systems, Inc. | JJE |
| Mar 17, 1992 | K915366 | MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER Ciba Corning Diagnostics Corp. | JJE |
| Jan 28, 1992 | K915106 | DIMENSION AR CLINICAL CHEMISTRY SYSTEM Dupont Medical Products | JJE |
| Sep 4, 1991 | K912844 | KODAK EKTACHEM DTII SYSTEM Eastman Kodak Company | JJE |
| Jul 19, 1991 | K912024 | AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R) Wako Chemicals USA, Inc. | JJE |
| Apr 3, 1991 | K910185 | SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER Beckman Instruments, Inc. | JJE |
| Oct 22, 1990 | K904219 | SYNCHRON CX 7 CLINICAL ANALYZER Beckman | JJE |
| Oct 15, 1990 | K904220 | SYNCHRON CX4-CE Beckman | JJE |
| Sep 27, 1990 | K903071 | KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN Eastman Kodak Company | JJE |
| Jul 10, 1990 | K902689 | ATAC 6000 CHEMISTRY ANALYZER Bio-Chem Laboratories | JJE |
| Jun 18, 1990 | K902336 | CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE Ciba Corning Diagnostics Corp. | JJE |
| Apr 16, 1990 | K901346 | ES 300 IMMUNOASSAY SYSTEM Boehringer Mannheim Corp. | JJE |
| Apr 16, 1990 | K901003 | BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER Boehringer Mannheim Corp. | JJE |
| Oct 4, 1989 | K895423 | ACCESS CHEMISTRY ANALYZER American Monitor Corp. | JJE |
| Sep 28, 1989 | K894222 | TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL Abbott Laboratories | JJE |
| Aug 10, 1989 | K893137 | EXCEL (TM) CHEMISTRY ANALYZER American Monitor Corp. | JJE |
| Aug 3, 1989 | K893776 | ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER Abbott Laboratories | JJE |
| Aug 3, 1989 | K893547 | CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER Heraeus Kulzer, Inc. | JJE |
| Mar 28, 1989 | K890929 | KODAK EKTACHEM 750 SERIES ANALYZER Eastman Kodak Company | JJE |
| Mar 28, 1989 | K890928 | KODAK EKTACHEM 500 ANALYZER Eastman Kodak Company | JJE |
| Mar 28, 1989 | K890927 | KODAK EKTACHEM 500/750 SERIES ANALYZER, SOFT V1.0 Eastman Kodak Company | JJE |
| Feb 27, 1989 | K884378 | DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER Coulter Corp. | JJE |
| Feb 17, 1989 | K885226 | TECHNICON AXON(TM) SYSTEM Technicon Instruments Corp. | JJE |
| Feb 7, 1989 | K890184 | MODIFIED INTENDED USE OF CLEANING REAGENT KIT Hichem Diagnostics | JJE |
| Feb 7, 1989 | K890183 | MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL. Hichem Diagnostics | JJE |
| Feb 7, 1989 | K885289 | KODAK EKTACHEM 700 ANALYZER FAMILY, SOFT V5.0 Eastman Kodak Company | JJE |
| Feb 7, 1989 | K885288 | HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE Eastman Kodak Company | JJE |
| Dec 29, 1988 | K884035 | SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER Sclavo, Inc. | JJE |
| Dec 15, 1988 | K883533 | ABC FP ANALYZER Intl. Bioclinical, Inc. | JJE |
| Oct 31, 1988 | K883539 | SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER Serono-Baker Diagnostics, Inc. | JJE |
| Oct 25, 1988 | K883321 | CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST Heraeus Kulzer, Inc. | JJE |
| Sep 13, 1988 | K883209 | TECHNICON RA-100(TM) SYSTEM Technicon Instruments Corp. | JJE |
| Sep 8, 1988 | K882451 | OLYMPUS REPLY CHEMISTRY ANALYZER Olympus Corp. | JJE |
| Aug 30, 1988 | K882914 | VISTA INSTRUMENT Abbott Laboratories | JJE |
| Aug 30, 1988 | K882913 | DTR ANALYZER Abbott Laboratories | JJE |
| Aug 8, 1988 | K882559 | PROFILE ONE OMNI Modular Diagnostic Systems, Inc. | JJE |
| Aug 4, 1988 | K882194 | GEMINII GAMMA COUNTER Laboratory Technologies, Inc. | JJE |
| Aug 2, 1988 | K882307 | D-CHEM Photec Diagnostics, Inc. | JJE |
| Jul 28, 1988 | K882450 | GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK. Diamond Sensor Systems | JJE |
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