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
25–48 of 130
Cleared Jan 12, 2000
SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
K994325
Beckman Coulter, Inc.
Chemistry · 21d
Cleared Dec 22, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS
K994145
Ortho-Clinical Diagnostics, Inc.
Chemistry · 14d
Cleared Nov 09, 1999
WAKO BILIRUBIN CALIBRATOR
K993219
Wako Chemicals USA, Inc.
Chemistry · 43d
Cleared Dec 21, 1998
SYNCHRON SYSTEMS LIPID CALIBRATOR
K983640
Beckman Coulter, Inc.
Chemistry · 66d
Cleared May 23, 1997
AUTO HDL CHOLESTEROL CALIBRATOR
K970933
Pointe Scientific, Inc.,
Chemistry · 71d
Cleared Dec 24, 1996
WAKO DIRECT HDL-C
K963847
Wako Chemicals USA, Inc.
Chemistry · 90d
Cleared Jun 29, 1995
SYNCHRON ENZYME VALIDATOR SET
K951964
Beckman Instruments, Inc.
Chemistry · 63d
Cleared Jun 15, 1995
T-UPTAKE CALIBRATORS
K951585
Diagnostic Reagents, Inc.
Chemistry · 70d
Cleared May 17, 1995
IMX ESTRADIOL
K951629
Abbott Laboratories
Chemistry · 61d
Cleared Nov 21, 1994
CALIBRATORS
K944701
Diagnostic Reagents, Inc.
Chemistry · 59d
Cleared Mar 11, 1994
URINARY ALBUMIN CALIBRATOR
K936201
Dupont Medical Products
Chemistry · 72d
Cleared Aug 25, 1993
KING SODIUM/POTASSIUM STANDARD MODIFIED
K931834
King Diagnostics, Inc.
Chemistry · 152d
Cleared Aug 19, 1993
DC-LINEATE CAT. NO. SE-091
K932555
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 85d
Cleared Aug 09, 1993
DU PONT ACA NEV/EEV VERIFIER
K930501
Dupont Medical Products
Chemistry · 189d
Cleared Jun 25, 1993
REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM
K922646
Behring Diagnostics, Inc.
Chemistry · 387d
Cleared Jun 07, 1993
ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR
K930477
Analytical Control Systems, Inc.
Chemistry · 129d
Cleared Mar 18, 1993
DC-UIBC-CAL
K925877
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 119d
Cleared Sep 23, 1992
DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR
K922699
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 111d
Cleared Sep 09, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR
K922698
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 97d
Cleared Aug 12, 1992
DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO
K922696
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 69d
Cleared Aug 03, 1992
BIOTROL BICARBONATE STANDARDS
K921855
Biotrol, USA, Inc.
Chemistry · 108d
Cleared Apr 17, 1992
KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD
K920809
King Diagnostics, Inc.
Chemistry · 56d
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