Product code JIS— Clinical Chemistry
80 MG/DL GLUCOSE CONTROL
- Classification name
- Calibrator, Primary
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Total cleared
- 130
- First cleared
- Most recent
Market context for product code JIS
FDA has cleared devices under product code JIS between 1976 and 2012, filed by 63 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2012
- 2006
- 2005
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
Top applicants under product code JIS
Recent clearances under product code JIS
1–100 of 130- K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
- K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
- K060266 — DIMENSION IRON CALIBRATOR
- K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
- K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
- K032608 — GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER
- K032296 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS
- K030964 — CALIBRATION PLASMA LMW HEPARIN
- K030546 — CRP (II) CALIBRATORS
- K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
- K022682 — RANDOX C-REACTIVE PROTEIN CALIBRATOR
- K022901 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS
- K013126 — N LP(A) STANDARD SY
- K012878 — THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
- K011568 — RANDOX LIPOPROTEIN
- K010696 — BECKMAN COULTER DNASE B CALIBRATOR
- K003941 — ELECSYS HCG STAT CLASET II
- K003969 — ELECSYS CA 125 II CALSET
- K002760 — ELECSYS DHEA-S CALSET
- K002353 — ELECSYS CA 15-3 CALCHECK
- K001906 — ELECSYS INSULIN CALSET
- K001004 — WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
- K001005 — WAKO HDL-C/LDL-C CALIBRATOR
- K001002 — WAKO LIPASE CALIBRATOR
- K000331 — SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
- K994168 — SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR
- K994169 — SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR
- K994114 — DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
- K994325 — SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
- K994145 — VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS
- K993219 — WAKO BILIRUBIN CALIBRATOR
- K983640 — SYNCHRON SYSTEMS LIPID CALIBRATOR
- K970933 — AUTO HDL CHOLESTEROL CALIBRATOR
- K963847 — WAKO DIRECT HDL-C
- K964475 — CLINICAL BLOOD GAS MIXTURES
- K954546 — BLOOD GAS MIXTURE
- K951964 — SYNCHRON ENZYME VALIDATOR SET
- K951585 — T-UPTAKE CALIBRATORS
- K951629 — IMX ESTRADIOL
- K944701 — CALIBRATORS
- K940008 — GLYCATED PROTEIN CALIBRATORS
- K936201 — URINARY ALBUMIN CALIBRATOR
- K931834 — KING SODIUM/POTASSIUM STANDARD MODIFIED
- K932555 — DC-LINEATE CAT. NO. SE-091
- K930501 — DU PONT ACA NEV/EEV VERIFIER
- K922646 — REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM
- K930477 — ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR
- K925877 — DC-UIBC-CAL
- K924904 — HDL-CHOLESTEROL STANDARD, MODIFICATION
- K922699 — DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR
- K922698 — DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR
- K922696 — DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO
- K921855 — BIOTROL BICARBONATE STANDARDS
- K921903 — THYROXINE CALIBRATOR KIT
- K920809 — KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD
- K910721 — BIOTROL PROTEIN MULTILEVEL STANDARDS
- K905820 — ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI
- K905477 — OLYMPUS URINE PH CALIBRATORS LEVELS I AND II
- K901113 — MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD
- K895778 — QUANTIMETRIX BILIRUBIN CALIBRATORS
- K895585 — HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)
- K884168 — ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.
- K882726 — RAICHEM(TM) BILIRUBIN STANDARD
- K881693 — TERUMO SENSIBEAD EIA PROGESTERONE KIT
- K872051 — CALCIUM CALIBRATOR
- K871185 — LITHIUM INTERNAL STANDARD 1 MEQ/L #60085
- K871186 — CESIUM DILUENT 1.5 MMOL CS/L #60087
- K871187 — LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084
- K871188 — LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086
- K870379 — ISE COMPENSATION SERA
- K862453 — EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
- K862704 — EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
- K861768 — THEOPHYLLINE (FPIA) CALIBRATOR KIT
- K861769 — GENTAMICIN (FPIA) CALIBRATOR KIT
- K861770 — PHENYTOIN (FPIA) CALIBRATOR KIT
- K861891 — TOBRAMYCIN (FPIA) CALIBRATOR KIT
- K855040 — SERALYZER TOTAL BILIRUBIN CALIBRATORS
- K852068 — TOTAL BILIRUBIN STANDARDS
- K844581 — 80 MG/DL GLUCOSE CONTROL
- K844235 — CHLORIDE STANDARD
- K843110 — ROCHE STANDARDS FOR CHOLESTEROL
- K842449 — HICHEM ION 2/4 SERUM RANGE CALIBRATOR
- K842450 — HICHEM ION 2/4 URINE RANGE CALIBRATOR
- K841955 — DUPONT ACA MAGNESIUM CALIBRATOR
- K840217 — CHOLESTEROL AQUEOUS STANDARD
- K840220 — HDL CHOLESTEROL AQUEOUS STANDARDS
- K840299 — PH ELECTRODE CALIBRATING BUFFERS-BLOOD
- K832251 — PRECISET CHOLESTEROL HIGH PERFORM
- K830283 — LITHIUM DILUENT
- K830137 — CALIBRATOR A
- K823147 — URIC ACID STANDARD, 8MG/DL #65078
- K822473 — CALCIUM STANDARD, ITEM #65075
- K822477 — CREATININE STANDARD #65072
- K822474 — CHOLESTEROL STANDARD #65077
- K822476 — PHOSPHOROUS STANDARD #65073
- K822232 — ACA URINARY PROTEIN CALIBRATOR
- K822332 — C-REACTIVE PROTEIN TEST KIT
- K821934 — BIO-CAL OPERATION CHECK KIT
- K821937 — SYVA ADVANCE STANDARDIZATION KIT #2
- K821938 — SYVA ADVANCE STANDARDIZATION KIT #3
Data sourced from openFDA. This site is unofficial and independent of the FDA.