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
97–120 of 130
Cleared Mar 24, 1981
EMIT-TFG PRISMA THYROXINE CALIBRATORS
K810587
Syva Co.
Chemistry · 20d
Cleared Feb 02, 1981
CHOLESTEROL STANDARD
K810092
Anco Medical Reagents & Assoc.
Chemistry · 20d
Cleared Jan 26, 1981
GLUCOSE STANDARD
K810091
Anco Medical Reagents & Assoc.
Chemistry · 13d
Cleared Dec 11, 1980
CREATININE STANDARDS
K802631
Gilford Diagnostics
Chemistry · 49d
Cleared Sep 26, 1980
UV URIC ACID STANDARDS
K801501
The Dow Chemical Co.
Chemistry · 91d
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 Apr 04, 1980
NSI CALIBRATOR SET
K800588
Nobel Scientific Industries, Inc.
Chemistry · 18d
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
Cleared Oct 21, 1976
REFEREE AQUEOUS TRIGLYCERIDE STND
K760806
Analytical Products, Inc.
Chemistry · 9d