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)
Top companies in JIX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 14, 2001 | K011035 | DIMENSION DRUG CALIBRATOR, MODEL DC22B Dade Behring, Inc. | JIX |
| Mar 30, 2001 | K010652 | SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 Sigma Diagnostics, Inc. | JIX |
| Feb 14, 2001 | K010030 | LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR Synergent Biochem Inc.-Clinical Controls Div. | JIX |
| Oct 5, 2000 | K002804 | N PROTEIN STANDARD SL Dade Behring, Inc. | JIX |
| Jun 19, 2000 | K001484 | CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 Alko Diagnostic Corp. | JIX |
| Mar 21, 2000 | K000576 | ELECSYS CORTISOL CALCHECK Roche Diagnostics Corp. | JIX |
| Dec 27, 1999 | K993853 | K-ASSAY MULTI-ANALYTE CALIBRATOR Kamiya Biomedical Co. | JIX |
| Nov 26, 1999 | K993606 | K-ASSAY APO A1/B CALIBRATOR SET Kamiya Biomedical Co. | JIX |
| Oct 18, 1999 | K992845 | HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT Elan Holdings, Inc. | JIX |
| Oct 8, 1999 | K993098 | HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 Data Medical Associates, Inc. | JIX |
| Aug 19, 1999 | K992086 | OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2 Olympus America, Inc. | JIX |
| Jun 10, 1999 | K991166 | K-ASSAY MICROALBUMIN CALIBRATOR SET Kamiya Biomedical Co. | JIX |
| Jun 1, 1999 | K991181 | MODIFICATION OF N PROTEIN STANDARD SL Dade Behring, Inc. | JIX |
| Mar 22, 1999 | K990460 | CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) Roche Diagnostics Corp. | JIX |
| Jan 20, 1999 | K984425 | MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR Boehringer Mannheim Corp. | JIX |
| Dec 23, 1998 | K984014 | SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 Beckman Coulter, Inc. | JIX |
| Nov 25, 1998 | K983469 | PRECISET SERUM PROTEINS CALIBRATOR Boehringer Mannheim Corp. | JIX |
| Sep 21, 1998 | K982767 | RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR Raichem | JIX |
| Sep 1, 1998 | K982501 | ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 Alko Diagnostic Corp. | JIX |
| Jul 9, 1998 | K981706 | AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 Abbott Laboratories | JIX |
| Jun 12, 1998 | K981795 | CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO Thermo Bioanalysis Corp. | JIX |
| May 7, 1998 | K981305 | OLYMPUS SERUM PROTEIN MULTICALIBRATOR Olympus America, Inc. | JIX |
| Apr 24, 1998 | K981436 | DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 Casco Standards | JIX |
| Jan 30, 1998 | K974825 | BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS Boehringer Mannheim Corp. | JIX |
| Dec 19, 1997 | K974290 | MICROPROTEIN STANDARD KIT Verichem Laboratories, Inc. | JIX |
| Dec 15, 1997 | K973932 | BECKMAN CALIBRATOR 2 (CAL2) Beckman Instruments, Inc. | JIX |
| Dec 1, 1997 | K973928 | BECKMAN URINE PROTEIN CALIBRATOR (UCAL) Beckman Instruments, Inc. | JIX |
| Oct 29, 1997 | K973345 | MATRIX PLUS MULTI-CALIBRATOR KIT Verichem Laboratories, Inc. | JIX |
| Jul 23, 1997 | K972333 | AMMONIA/IRON STANDARD KIT Verichem Laboratories, Inc. | JIX |
| Jun 3, 1997 | K971283 | SYNCHRON SYSTEMS CAL 5 PLUS Beckman Instruments, Inc. | JIX |
| May 23, 1997 | K971333 | SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD Beckman Instruments, Inc. | JIX |
| Apr 8, 1997 | K970921 | STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) Alko Diagnostic Corp. | JIX |
| Jan 15, 1997 | K964527 | N RHEUMATOLOGY STANDARD SL Behring Diagnostics, Inc. | JIX |
| Dec 16, 1996 | K964829 | ELECSYS CALCHECK FSH Boehringer Mannheim Corp. | JIX |
| Nov 21, 1996 | K964062 | N PROTEIN STRANDARD SL Behring Diagnostics, Inc. | JIX |
| Oct 30, 1996 | K963543 | SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2 Sigma Diagnostics, Inc. | JIX |
| Oct 29, 1996 | K963533 | SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1 Sigma Diagnostics, Inc. | JIX |
| Oct 29, 1996 | K962269 | CEDIA CARDIAC TDM MULTI-CALS Boehringer Mannheim Corp. | JIX |
| Sep 13, 1996 | K962629 | DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR Casco Standards | JIX |
| Jul 16, 1996 | K962410 | N PROTEIN STANDARD PY Behring Diagnostics, Inc. | JIX |
| Jul 16, 1996 | K962406 | N CRP STANDARD SY Behring Diagnostics, Inc. | JIX |
| Jun 21, 1996 | K955489 | CALIBRATION SERUM LEVEL 1 & 2 Randox Laboratories, Ltd., IE | JIX |
| Jun 13, 1996 | K961659 | CEDIA CORE TDM MULTI-CAL Boehringer Mannheim Corp. | JIX |
| Apr 26, 1996 | K960103 | DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS Dade Intl., Inc. | JIX |
| Mar 11, 1996 | K960085 | ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS Alko Diagnostic Corp. | JIX |
| Dec 11, 1995 | K955154 | CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT Alko Diagnostic Corp. | JIX |
| Oct 3, 1995 | K953979 | APOLIPOPROTEIN CALIBRATOR (APO-CAL) Beckman Instruments, Inc. | JIX |
| Sep 20, 1995 | K942706 | ROCHE CALIBRATOR SERUM Roche Diagnostic Systems, Inc. | JIX |
| Sep 15, 1995 | K952282 | ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR Roche Diagnostic Systems, Inc. | JIX |
| Sep 6, 1995 | K953863 | HICHEM ISE STANDARDS KIT 70011 Hichem Diagnostics | JIX |
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