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 Dade Behring, Inc..

130
Total
130
Cleared
51d
Avg days
1976
Since
130 devices
73–96 of 130
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 Nov 22, 1982
URIC ACID STANDARD, 8MG/DL #65078
K823147
Harleco Diagnostics
Chemistry · 28d
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
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 20, 1982
BIO-CAL OPERATION CHECK KIT
K821934
Bio-Analytics Laboratories, Inc.
Chemistry · 21d
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 31, 1981
AQUEOUS TRIOLEIN STANDARDS & KITS
K810742
Supelco, Inc.
Chemistry · 12d
Cleared Mar 31, 1981
LECITHIN-SPINGOMYELIN STAND. & KITS
K810743
Supelco, Inc.
Chemistry · 12d