Atlas FDA

JIS

130 FDA 510(k) clearances · Product code

44 daysmedian time to decision
97 days90th percentile
130clearances measured

FDA profile

Official device name
Calibrator, Primary
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1150
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2011: 5 · 2012: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
DIRECT LDL/HDL CHOLESTEROL CALIBRATOR (K122126)Randox Laboratories Limited2012-08-14
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR (K061251)Dade Behring, Inc.2006-05-31
DIMENSION IRON CALIBRATOR (K060266)Dade Behring, Inc.2006-03-09
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR (K053104)Dade Behring, Inc.2005-12-23
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) (K032697)Dade Behring, Inc.2003-11-07
GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER (K032608)Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB2003-10-21
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS (K032296)Ortho-Clinical Diagnostics, Inc.2003-08-13
CALIBRATION PLASMA LMW HEPARIN (K030964)Instrumentation Laboratory CO2003-06-06
CRP (II) CALIBRATORS (K030546)Denka Seiken Co., Ltd.2003-06-02
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET (K030320)Wako Chemicals USA, Inc.2003-04-11
RANDOX C-REACTIVE PROTEIN CALIBRATOR (K022682)Randox Laboratories, Ltd.2002-11-05
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS (K022901)Ortho-Clinical Diagnostics2002-09-27
N LP(A) STANDARD SY (K013126)Dade Behring, Inc.2001-11-09
THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 (K012878)Thermo Dma, Inc.2001-10-16
RANDOX LIPOPROTEIN (K011568)Randox Laboratories, Ltd.2001-09-28
BECKMAN COULTER DNASE B CALIBRATOR (K010696)Beckman Coulter, Inc.2001-05-10
ELECSYS HCG STAT CLASET II (K003941)Roche Diagnostics Corp.2001-01-25
ELECSYS CA 125 II CALSET (K003969)Roche Diagnostics Corp.2001-01-12
ELECSYS DHEA-S CALSET (K002760)Roche Diagnostics Corp.2000-10-05
ELECSYS CA 15-3 CALCHECK (K002353)Roche Diagnostics Corp.2000-08-10
ELECSYS INSULIN CALSET (K001906)Roche Diagnostics Corp.2000-07-13
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR (K001004)Wako Chemicals USA, Inc.2000-06-01
WAKO HDL-C/LDL-C CALIBRATOR (K001005)Wako Chemicals USA, Inc.2000-06-01
WAKO LIPASE CALIBRATOR (K001002)Wako Chemicals USA, Inc.2000-05-24
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR (K000331)Beckman Coulter, Inc.2000-02-10
SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR (K994168)Beckman Coulter, Inc.2000-02-03
SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR (K994169)Beckman Coulter, Inc.2000-02-03
DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR (K994114)Dade Behring, Inc.2000-01-20
SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR (K994325)Beckman Coulter, Inc.2000-01-12
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS (K994145)Ortho-Clinical Diagnostics, Inc.1999-12-22
WAKO BILIRUBIN CALIBRATOR (K993219)Wako Chemicals USA, Inc.1999-11-09
SYNCHRON SYSTEMS LIPID CALIBRATOR (K983640)Beckman Coulter, Inc.1998-12-21
AUTO HDL CHOLESTEROL CALIBRATOR (K970933)Pointe Scientific, Inc.,1997-05-23
WAKO DIRECT HDL-C (K963847)Wako Chemicals USA, Inc.1996-12-24
CLINICAL BLOOD GAS MIXTURES (K964475)Oxarc, Inc.1996-12-06
BLOOD GAS MIXTURE (K954546)Liquid Technology Corp.1995-12-28
SYNCHRON ENZYME VALIDATOR SET (K951964)Beckman Instruments, Inc.1995-06-29
T-UPTAKE CALIBRATORS (K951585)Diagnostic Reagents, Inc.1995-06-15
IMX ESTRADIOL (K951629)Abbott Laboratories1995-05-17
CALIBRATORS (K944701)Diagnostic Reagents, Inc.1994-11-21
GLYCATED PROTEIN CALIBRATORS (K940008)Primus Corp.1994-05-09
URINARY ALBUMIN CALIBRATOR (K936201)Dupont Medical Products1994-03-11
KING SODIUM/POTASSIUM STANDARD MODIFIED (K931834)King Diagnostics, Inc.1993-08-25
DC-LINEATE CAT. NO. SE-091 (K932555)Diagnostic Chemicals, Ltd. (Usa)1993-08-19
DU PONT ACA NEV/EEV VERIFIER (K930501)Dupont Medical Products1993-08-09
REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM (K922646)Behring Diagnostics, Inc.1993-06-25
ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR (K930477)Analytical Control Systems, Inc.1993-06-07
DC-UIBC-CAL (K925877)Diagnostic Chemicals, Ltd. (Usa)1993-03-18
HDL-CHOLESTEROL STANDARD, MODIFICATION (K924904)Verichem Laboratories, Inc.1993-01-13
DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR (K922699)E.I. Dupont DE Nemours & Co., Inc.1992-09-23
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR (K922698)E.I. Dupont DE Nemours & Co., Inc.1992-09-09
DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO (K922696)E.I. Dupont DE Nemours & Co., Inc.1992-08-12
BIOTROL BICARBONATE STANDARDS (K921855)Biotrol, USA, Inc.1992-08-03
THYROXINE CALIBRATOR KIT (K921903)Tudor Laboratories, Inc.1992-05-26
KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD (K920809)King Diagnostics, Inc.1992-04-17
BIOTROL PROTEIN MULTILEVEL STANDARDS (K910721)Biotrol, USA, Inc.1991-05-06
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI (K905820)E.I. Dupont DE Nemours & Co., Inc.1991-02-26
OLYMPUS URINE PH CALIBRATORS LEVELS I AND II (K905477)Em Diagnostic Systems, Inc.1991-02-13
MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD (K901113)Verichem Laboratories, Inc.1990-03-29
QUANTIMETRIX BILIRUBIN CALIBRATORS (K895778)Quantimetrix Medical Industries1989-11-14
HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) (K895585)Hichem Diagnostics1989-11-13
ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA. (K884168)The DU Pont Co.1988-11-29
RAICHEM(TM) BILIRUBIN STANDARD (K882726)Reagents Applications, Inc.1988-08-29
TERUMO SENSIBEAD EIA PROGESTERONE KIT (K881693)Terumo Medical Corp.1988-06-07
CALCIUM CALIBRATOR (K872051)Wako Chemicals USA, Inc.1987-09-18
LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 (K871185)In Vitro Diagnostics, Inc.1987-05-28
LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084 (K871187)In Vitro Diagnostics, Inc.1987-05-28
LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086 (K871188)In Vitro Diagnostics, Inc.1987-05-28
CESIUM DILUENT 1.5 MMOL CS/L #60087 (K871186)In Vitro Diagnostics, Inc.1987-05-28
ISE COMPENSATION SERA (K870379)Boehringer Mannheim Corp.1987-02-26
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93 (K862453)Em Diagnostic Systems, Inc.1986-08-19
EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95 (K862704)Em Diagnostic Systems, Inc.1986-08-19
GENTAMICIN (FPIA) CALIBRATOR KIT (K861769)Windsor Laboratories, Inc.1986-06-25
TOBRAMYCIN (FPIA) CALIBRATOR KIT (K861891)Windsor Laboratories, Inc.1986-06-25
PHENYTOIN (FPIA) CALIBRATOR KIT (K861770)Windsor Laboratories, Inc.1986-06-25
THEOPHYLLINE (FPIA) CALIBRATOR KIT (K861768)Windsor Laboratories, Inc.1986-06-25
SERALYZER TOTAL BILIRUBIN CALIBRATORS (K855040)Miles Laboratories, Inc.1986-01-22
TOTAL BILIRUBIN STANDARDS (K852068)Data Medical Associates, Inc.1985-05-31
80 MG/DL GLUCOSE CONTROL (K844581)Boehringer Mannheim Corp.1984-12-12
CHLORIDE STANDARD (K844235)Shaban Mfg. Co.1984-11-20
ROCHE STANDARDS FOR CHOLESTEROL (K843110)Roche Diagnostic Systems, Inc.1984-09-04
HICHEM ION 2/4 SERUM RANGE CALIBRATOR (K842449)Hi Chem, Inc.1984-08-16
HICHEM ION 2/4 URINE RANGE CALIBRATOR (K842450)Hi Chem, Inc.1984-08-16
DUPONT ACA MAGNESIUM CALIBRATOR (K841955)E.I. Dupont DE Nemours & Co., Inc.1984-06-25
HDL CHOLESTEROL AQUEOUS STANDARDS (K840220)Preventive Diagnostics Corp.1984-03-23
CHOLESTEROL AQUEOUS STANDARD (K840217)Preventive Diagnostics Corp.1984-03-23
PH ELECTRODE CALIBRATING BUFFERS-BLOOD (K840299)Bionostics, Inc.1984-03-23
PRECISET CHOLESTEROL HIGH PERFORM (K832251)Boehringer Mannheim Corp.1983-08-24
LITHIUM DILUENT (K830283)Shaban Mfg. Co.1983-02-28
CALIBRATOR A (K830137)Hi Chem, Inc.1983-02-07
URIC ACID STANDARD, 8MG/DL #65078 (K823147)Harleco Diagnostics1982-11-22
CALCIUM STANDARD, ITEM #65075 (K822473)Emd Chemicals, Inc.1982-09-17
CREATININE STANDARD #65072 (K822477)Emd Chemicals, Inc.1982-09-17
CHOLESTEROL STANDARD #65077 (K822474)Emd Chemicals, Inc.1982-09-14
PHOSPHOROUS STANDARD #65073 (K822476)Emd Chemicals, Inc.1982-09-14
C-REACTIVE PROTEIN TEST KIT (K822332)Sclavo, Inc.1982-08-16
ACA URINARY PROTEIN CALIBRATOR (K822232)E.I. Dupont DE Nemours & Co., Inc.1982-08-16
BIO-CAL OPERATION CHECK KIT (K821934)Bio-Analytics Laboratories, Inc.1982-07-20
SYVA ADVANCE STANDARDIZATION KIT #2 (K821937)Syva Co.1982-07-16
SYVA ADVANCE STANDARDIZATION KIT #3 (K821938)Syva Co.1982-07-16
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