Panels › Clinical Chemistry › Product code JIT · Class 2
Calibrator, Secondary
Regulation 862.1150
0510(k)s in 12 months (245 all time)
1recalls in 12 months (55 all time)
40recalls that name a 510(k)
Top companies in JIT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 4, 2008 | K081319 | DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 Siemens Healthcare Diagnostics, Inc. | JIT |
| Jul 7, 2008 | K081683 | LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 Siemens Healthcare Diagnostics | JIT |
| Mar 19, 2008 | K080166 | ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545 Beckman Coulter, Inc. | JIT |
| Dec 12, 2007 | K072717 | DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 Dade Behring, Inc. | JIT |
| Aug 8, 2007 | K071039 | MISSION OLYMPUS AU ISE CALIBRATORS Diamond Diagnostics, Inc. | JIT |
| Apr 30, 2007 | K070552 | DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) Dade Behring, Inc. | JIT |
| Mar 16, 2007 | K062521 | OXALATE URINE CONTROLS (NORMAL AND ELEVATED) Thermo-Electron Corp., AU | JIT |
| Feb 1, 2007 | K070144 | INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc. | JIT |
| Aug 24, 2006 | K060854 | ABX PENTRA 400: LIPOPROTEINS Horiba Abx, FR | JIT |
| Aug 16, 2006 | K062152 | CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 Dade Behring, Inc. | JIT |
| Aug 14, 2006 | K061885 | DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250 Dade Behring, Inc. | JIT |
| Jul 18, 2006 | K061818 | DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) Dade Behring, Inc. | JIT |
| Jul 13, 2006 | K061751 | DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260 Dade Behring, Inc. | JIT |
| Jul 10, 2006 | K061702 | DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340) Dade Behring, Inc. | JIT |
| Jul 6, 2006 | K061139 | BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS Bayer Healthcare, LLC | JIT |
| Jun 2, 2006 | K061282 | ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585 Beckman Coulter, Inc. | JIT |
| Apr 24, 2006 | K060140 | CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 Diagnostic Chemicals , Ltd., CA | JIT |
| Apr 18, 2006 | K060754 | ELECSYS TSH CALSET W/MODELS 04738551 Roche Diagnostics Corp. | JIT |
| Apr 14, 2006 | K060359 | ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 Denka Seiken Co., Ltd., JP | JIT |
| Mar 21, 2006 | K060322 | CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED Cliniqa Corporation | JIT |
| Mar 13, 2006 | K053291 | FERRITIN CALIBRATOR SET, CATALOG NO. 8203 Reference Diagnostics, Inc. | JIT |
| Mar 9, 2006 | K060371 | THE EMIT 2000 TACROLIMUS CALIBRATORS Dade Behring, Inc. | JIT |
| Feb 7, 2006 | K053576 | DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR Dade Behring, Inc. | JIT |
| Dec 16, 2005 | K053330 | ARCHITECT B12 CALIBRATORS Abbott Laboratories | JIT |
| Nov 9, 2005 | K052148 | TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET Reference Diagnostics, Inc. | JIT |
| Oct 28, 2005 | K052982 | ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET Roche Diagnostics | JIT |
| Oct 3, 2005 | K052193 | ISE COMPENSATOR Roche Diagnostics | JIT |
| Aug 22, 2005 | K052002 | IRON STANDARD Roche Diagnostics Corp. | JIT |
| Jul 19, 2005 | K051012 | PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML. Salimetrics, LLC | JIT |
| Jul 6, 2005 | K050231 | ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET Roche Diagnostics Corp. | JIT |
| Dec 29, 2004 | K043378 | DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT Drew Scientific , Ltd., GB | JIT |
| Dec 9, 2004 | K042838 | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II Ortho-Clinical Diagnostics, Inc. | JIT |
| Dec 3, 2004 | K042406 | OLYMPUS LACTATE, OSR6193 Olympus America, Inc. | JIT |
| Nov 23, 2004 | K043095 | ROCHE DIAGNOSTICS ELECSYS AFP CALSET II Roche Diagnostics Corp. | JIT |
| Nov 18, 2004 | K042521 | VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS Ortho-Clinical Diagnostics, Inc. | JIT |
| Nov 3, 2004 | K042307 | ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) Seradyn, Inc. | JIT |
| Oct 5, 2004 | K042651 | FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc. | JIT |
| Sep 30, 2004 | K042490 | ELECSYS FOLATE II CALSET II Roche Diagnostics Corp. | JIT |
| Apr 23, 2004 | K033860 | AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR Wako Chemicals USA, Inc. | JIT |
| Apr 8, 2004 | K040692 | OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023 Olympus America, Inc. | JIT |
| Mar 25, 2004 | K040226 | WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET Wako Chemicals USA, Inc. | JIT |
| Mar 10, 2004 | K040471 | OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024 Olympus America, Inc. | JIT |
| Mar 4, 2004 | K033060 | CALIBRATING MATERIAL, CALIBRATING STANDARDS Diamond Diagnostics, Inc. | JIT |
| Feb 27, 2004 | K033786 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA Ibl GmbH | JIT |
| Jan 8, 2004 | K033643 | CO2 CALIBRATOR/DILUENT Bayer Healthcare, Diagnostics Division | JIT |
| Oct 6, 2003 | K032458 | ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT Abbott Laboratories | JIT |
| Aug 21, 2003 | K032285 | OLYMPUS PREALBUMIN CALIBRATOR, ODR3029 Olympus America, Inc. | JIT |
| Aug 7, 2003 | K031924 | VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 Ortho-Clinical Diagnostics | JIT |
| Jun 25, 2003 | K031159 | CALIBRATING MATERIAL, CALIBRATING STANDARDS Diamond Diagnostics, Inc. | JIT |
| May 12, 2003 | K031299 | ELECSYS LH CALSET II Roche Diagnostics Corp. | JIT |
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