JIS · Class II · 21 CFR 862.1150

FDA Product Code JIS: Calibrator, Primary

Leading manufacturers include E.I. Dupont DE Nemours & Co., Inc., Wako Chemicals USA, Inc. and Beckman Coulter, Inc..

130
Total
130
Cleared
51d
Avg days
1976
Since
130 devices
49–72 of 130
Cleared May 06, 1991
BIOTROL PROTEIN MULTILEVEL STANDARDS
K910721
Biotrol, USA, Inc.
Chemistry · 75d
Cleared Feb 26, 1991
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI
K905820
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 57d
Cleared Feb 13, 1991
OLYMPUS URINE PH CALIBRATORS LEVELS I AND II
K905477
Em Diagnostic Systems, Inc.
Chemistry · 69d
Cleared Nov 13, 1989
HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)
K895585
Hichem Diagnostics
Chemistry · 59d
Cleared Aug 29, 1988
RAICHEM(TM) BILIRUBIN STANDARD
K882726
Reagents Applications, Inc.
Chemistry · 59d
Cleared Jun 07, 1988
TERUMO SENSIBEAD EIA PROGESTERONE KIT
K881693
Terumo Medical Corp.
Chemistry · 49d
Cleared Sep 18, 1987
CALCIUM CALIBRATOR
K872051
Wako Chemicals USA, Inc.
Chemistry · 113d
Cleared Feb 26, 1987
ISE COMPENSATION SERA
K870379
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Aug 19, 1986
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
K862453
Em Diagnostic Systems, Inc.
Chemistry · 53d
Cleared Aug 19, 1986
EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
K862704
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jun 25, 1986
THEOPHYLLINE (FPIA) CALIBRATOR KIT
K861768
Windsor Laboratories, Inc.
Toxicology · 49d
Cleared Jun 25, 1986
GENTAMICIN (FPIA) CALIBRATOR KIT
K861769
Windsor Laboratories, Inc.
Toxicology · 49d
Cleared Jun 25, 1986
PHENYTOIN (FPIA) CALIBRATOR KIT
K861770
Windsor Laboratories, Inc.
Toxicology · 49d
Cleared Jun 25, 1986
TOBRAMYCIN (FPIA) CALIBRATOR KIT
K861891
Windsor Laboratories, Inc.
Toxicology · 40d
Cleared Jan 22, 1986
SERALYZER TOTAL BILIRUBIN CALIBRATORS
K855040
Miles Laboratories, Inc.
Chemistry · 36d
Cleared May 31, 1985
TOTAL BILIRUBIN STANDARDS
K852068
Data Medical Associates, Inc.
Chemistry · 21d
Cleared Dec 12, 1984
80 MG/DL GLUCOSE CONTROL
K844581
Boehringer Mannheim Corp.
Chemistry · 19d
Cleared Nov 20, 1984
CHLORIDE STANDARD
K844235
Shaban Mfg. Co.
Chemistry · 19d
Cleared Sep 04, 1984
ROCHE STANDARDS FOR CHOLESTEROL
K843110
Roche Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Aug 16, 1984
HICHEM ION 2/4 SERUM RANGE CALIBRATOR
K842449
Hi Chem, Inc.
Chemistry · 55d
Cleared Aug 16, 1984
HICHEM ION 2/4 URINE RANGE CALIBRATOR
K842450
Hi Chem, Inc.
Chemistry · 55d
Cleared Jun 25, 1984
DUPONT ACA MAGNESIUM CALIBRATOR
K841955
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 42d
Cleared Mar 23, 1984
CHOLESTEROL AQUEOUS STANDARD
K840217
Preventive Diagnostics Corp.
Chemistry · 64d
Cleared Mar 23, 1984
HDL CHOLESTEROL AQUEOUS STANDARDS
K840220
Preventive Diagnostics Corp.
Chemistry · 64d