Panels › Clinical Chemistry › Product code JIS · Class 2
Calibrator, Primary
Regulation 862.1150
0510(k)s in 12 months (130 all time)
0recalls in 12 months (21 all time)
15recalls that name a 510(k)
Top companies in JIS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 14, 2012 | K122126 | DIRECT LDL/HDL CHOLESTEROL CALIBRATOR Randox Laboratories Limited, GA | JIS |
| May 31, 2006 | K061251 | DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR Dade Behring, Inc. | JIS |
| Mar 9, 2006 | K060266 | DIMENSION IRON CALIBRATOR Dade Behring, Inc. | JIS |
| Dec 23, 2005 | K053104 | DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR Dade Behring, Inc. | JIS |
| Nov 7, 2003 | K032697 | DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) Dade Behring, Inc. | JIS |
| Oct 21, 2003 | K032608 | GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB, DE | JIS |
| Aug 13, 2003 | K032296 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, Inc. | JIS |
| Jun 6, 2003 | K030964 | CALIBRATION PLASMA LMW HEPARIN Instrumentation Laboratory CO | JIS |
| Jun 2, 2003 | K030546 | CRP (II) CALIBRATORS Denka Seiken Co., Ltd., JP | JIS |
| Apr 11, 2003 | K030320 | WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET Wako Chemicals USA, Inc. | JIS |
| Nov 5, 2002 | K022682 | RANDOX C-REACTIVE PROTEIN CALIBRATOR Randox Laboratories, Ltd., GB | JIS |
| Sep 27, 2002 | K022901 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics | JIS |
| Nov 9, 2001 | K013126 | N LP(A) STANDARD SY Dade Behring, Inc. | JIS |
| Oct 16, 2001 | K012878 | THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 Thermo Dma, Inc. | JIS |
| Sep 28, 2001 | K011568 | RANDOX LIPOPROTEIN Randox Laboratories, Ltd., GB | JIS |
| May 10, 2001 | K010696 | BECKMAN COULTER DNASE B CALIBRATOR Beckman Coulter, Inc. | JIS |
| Jan 25, 2001 | K003941 | ELECSYS HCG STAT CLASET II Roche Diagnostics Corp. | JIS |
| Jan 12, 2001 | K003969 | ELECSYS CA 125 II CALSET Roche Diagnostics Corp. | JIS |
| Oct 5, 2000 | K002760 | ELECSYS DHEA-S CALSET Roche Diagnostics Corp. | JIS |
| Aug 10, 2000 | K002353 | ELECSYS CA 15-3 CALCHECK Roche Diagnostics Corp. | JIS |
| Jul 13, 2000 | K001906 | ELECSYS INSULIN CALSET Roche Diagnostics Corp. | JIS |
| Jun 1, 2000 | K001005 | WAKO HDL-C/LDL-C CALIBRATOR Wako Chemicals USA, Inc. | JIS |
| Jun 1, 2000 | K001004 | WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR Wako Chemicals USA, Inc. | JIS |
| May 24, 2000 | K001002 | WAKO LIPASE CALIBRATOR Wako Chemicals USA, Inc. | JIS |
| Feb 10, 2000 | K000331 | SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR Beckman Coulter, Inc. | JIS |
| Feb 3, 2000 | K994169 | SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR Beckman Coulter, Inc. | JIS |
| Feb 3, 2000 | K994168 | SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR Beckman Coulter, Inc. | JIS |
| Jan 20, 2000 | K994114 | DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR Dade Behring, Inc. | JIS |
| Jan 12, 2000 | K994325 | SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR Beckman Coulter, Inc. | JIS |
| Dec 22, 1999 | K994145 | VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS Ortho-Clinical Diagnostics, Inc. | JIS |
| Nov 9, 1999 | K993219 | WAKO BILIRUBIN CALIBRATOR Wako Chemicals USA, Inc. | JIS |
| Dec 21, 1998 | K983640 | SYNCHRON SYSTEMS LIPID CALIBRATOR Beckman Coulter, Inc. | JIS |
| May 23, 1997 | K970933 | AUTO HDL CHOLESTEROL CALIBRATOR Pointe Scientific, Inc., | JIS |
| Dec 24, 1996 | K963847 | WAKO DIRECT HDL-C Wako Chemicals USA, Inc. | JIS |
| Dec 6, 1996 | K964475 | CLINICAL BLOOD GAS MIXTURES Oxarc, Inc. | JIS |
| Dec 28, 1995 | K954546 | BLOOD GAS MIXTURE Liquid Technology Corp. | JIS |
| Jun 29, 1995 | K951964 | SYNCHRON ENZYME VALIDATOR SET Beckman Instruments, Inc. | JIS |
| Jun 15, 1995 | K951585 | T-UPTAKE CALIBRATORS Diagnostic Reagents, Inc. | JIS |
| May 17, 1995 | K951629 | IMX ESTRADIOL Abbott Laboratories | JIS |
| Nov 21, 1994 | K944701 | CALIBRATORS Diagnostic Reagents, Inc. | JIS |
| May 9, 1994 | K940008 | GLYCATED PROTEIN CALIBRATORS Primus Corp. | JIS |
| Mar 11, 1994 | K936201 | URINARY ALBUMIN CALIBRATOR Dupont Medical Products | JIS |
| Aug 25, 1993 | K931834 | KING SODIUM/POTASSIUM STANDARD MODIFIED King Diagnostics, Inc. | JIS |
| Aug 19, 1993 | K932555 | DC-LINEATE CAT. NO. SE-091 Diagnostic Chemicals, Ltd. (Usa), CA | JIS |
| Aug 9, 1993 | K930501 | DU PONT ACA NEV/EEV VERIFIER Dupont Medical Products | JIS |
| Jun 25, 1993 | K922646 | REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM Behring Diagnostics, Inc. | JIS |
| Jun 7, 1993 | K930477 | ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR Analytical Control Systems, Inc. | JIS |
| Mar 18, 1993 | K925877 | DC-UIBC-CAL Diagnostic Chemicals, Ltd. (Usa), CA | JIS |
| Jan 13, 1993 | K924904 | HDL-CHOLESTEROL STANDARD, MODIFICATION Verichem Laboratories, Inc. | JIS |
| Sep 23, 1992 | K922699 | DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR E.I. Dupont DE Nemours & Co., Inc. | JIS |
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