JIS · Class II · 21 CFR 862.1150

FDA Product Code JIS: Calibrator, Primary

Leading manufacturers include E.I. Dupont DE Nemours & Co., Inc., Dade Behring, Inc. and Syva Co..

130
Total
130
Cleared
51d
Avg days
1976
Since
130 devices
25–48 of 130
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 Jun 07, 1988
TERUMO SENSIBEAD EIA PROGESTERONE KIT
K881693
Terumo Medical Corp.
Chemistry · 49d
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 Dec 12, 1984
80 MG/DL GLUCOSE CONTROL
K844581
Boehringer Mannheim Corp.
Chemistry · 19d
Cleared Sep 04, 1984
ROCHE STANDARDS FOR CHOLESTEROL
K843110
Roche Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Jun 25, 1984
DUPONT ACA MAGNESIUM CALIBRATOR
K841955
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 42d
Cleared Aug 24, 1983
PRECISET CHOLESTEROL HIGH PERFORM
K832251
Boehringer Mannheim Corp.
Chemistry · 44d
Cleared Aug 16, 1982
ACA URINARY PROTEIN CALIBRATOR
K822232
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 20d
Cleared Jul 16, 1982
SYVA ADVANCE STANDARDIZATION KIT #2
K821937
Syva Co.
Chemistry · 17d
Cleared Jul 16, 1982
SYVA ADVANCE STANDARDIZATION KIT #3
K821938
Syva Co.
Chemistry · 17d
Cleared Jul 02, 1982
BECKMAN URIC ACID STANDARD
K821813
Beckman Instruments, Inc.
Chemistry · 14d
Cleared May 03, 1982
ACE ALBUMIN CALIBRATOR
K821061
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 18d
Cleared Apr 01, 1982
SYVA ADVANCE STANDARDIZATION KIT 01
K820698
Syva Co.
Chemistry · 17d
Cleared Apr 17, 1981
BIO SET TM SUBSTRATE CALIBRATORS
K810963
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Mar 24, 1981
EMIT-TFG PRISMA THYROXINE CALIBRATORS
K810587
Syva Co.
Chemistry · 20d
Cleared Aug 20, 1980
SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH)
K801665
Miles Laboratories, Inc.
Chemistry · 30d
Cleared Jun 30, 1980
EMIT AAII THYROXINE CALIBRATORS
K801287
Syva Co.
Chemistry · 31d
Cleared Mar 03, 1980
ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT.
K800206
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 33d
Cleared Aug 16, 1979
SPECTRO-SUR SET
K791315
Helena Laboratories
Chemistry · 31d
Cleared Dec 04, 1978
CHOLESTEROL STANDARDS
K781853
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 28d