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
73–96 of 130
Cleared Aug 16, 1982
ACA URINARY PROTEIN CALIBRATOR
K822232
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 20d
Cleared Aug 16, 1982
C-REACTIVE PROTEIN TEST KIT
K822332
Sclavo, Inc.
Chemistry · 12d
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 Dec 31, 1981
FLAME PHOTOMETER CALIBRATION STANDARDS
K813505
Fisher Scientific Co., LLC
Chemistry · 16d
Cleared Dec 22, 1981
TRIGLYCERIDE CALIBRATORS
K813478
Gilford Diagnostics
Chemistry · 21d
Cleared Oct 23, 1981
CHOLESTEROL CALIBRATORS
K812861
Gilford Diagnostics
Chemistry · 10d
Cleared Apr 17, 1981
BIO SET TM SUBSTRATE CALIBRATORS
K810963
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Apr 14, 1981
FOLLICLE STIMULATING HORMONE (FSH)
K810867
Pcl-Ria, Inc.
Chemistry · 14d
Cleared Mar 24, 1981
EMIT-TFG PRISMA THYROXINE CALIBRATORS
K810587
Syva Co.
Chemistry · 20d
Cleared Dec 11, 1980
CREATININE STANDARDS
K802631
Gilford Diagnostics
Chemistry · 49d
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 Feb 11, 1980
PIPET CALIBRATION KIT
K800062
Streck Laboratories, Inc.
Chemistry · 31d
Cleared Jan 21, 1980
LITHIUM STANDARD (1MM/L)
K800042
Gilford Diagnostics
Chemistry · 14d
Cleared Oct 30, 1979
URIC ACID STANDARD
K792046
Gilford Diagnostics
Chemistry · 18d
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
Cleared Apr 24, 1978
EMIT ANTIEPILEPTIC DRUG CALIBRATORS
K780467
Syva Co.
Toxicology · 33d
Cleared Jan 26, 1977
BIO TROL-T TRIOLEIN SOLUTIONS
K770072
Boehringer Mannheim Corp.
Chemistry · 13d