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 Syva Co..

130
Total
130
Cleared
51d
Avg days
1976
Since
130 devices
49–72 of 130
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 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
PH ELECTRODE CALIBRATING BUFFERS-BLOOD
K840299
Bionostics, Inc.
Chemistry · 59d
Cleared Aug 24, 1983
PRECISET CHOLESTEROL HIGH PERFORM
K832251
Boehringer Mannheim Corp.
Chemistry · 44d
Cleared Feb 28, 1983
LITHIUM DILUENT
K830283
Shaban Mfg. Co.
Chemistry · 33d
Cleared Feb 07, 1983
CALIBRATOR A
K830137
Hi Chem, Inc.
Chemistry · 25d
Cleared Sep 17, 1982
CALCIUM STANDARD, ITEM #65075
K822473
Emd Chemicals, Inc.
Chemistry · 31d
Cleared Sep 17, 1982
CREATININE STANDARD #65072
K822477
Emd Chemicals, Inc.
Chemistry · 31d
Cleared Sep 14, 1982
CHOLESTEROL STANDARD #65077
K822474
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
PHOSPHOROUS STANDARD #65073
K822476
Emd Chemicals, Inc.
Chemistry · 28d