JIX · Class II · 21 CFR 862.1150

FDA Product Code JIX: Calibrator, Multi-analyte Mixture

Leading manufacturers include Alko Diagnostic Corp., Dade Behring, Inc. and Bhp Diagnostix, Inc..

302
Total
302
Cleared
66d
Avg days
1976
Since
302 devices
241–264 of 302
Cleared Jan 22, 1982
SODIUM & POTASSIUM PRODUCTS
K813127
Alko Diagnostic Corp.
Chemistry · 78d
Cleared Oct 19, 1981
BECKMAN ICS CALIBRATOR
K812649
Beckman Instruments, Inc.
Chemistry · 32d
Cleared Jul 23, 1981
HITACHI 705 CALIBRATOR
K811921
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Apr 17, 1981
BIO SET TM PHOSPHOROUS CALIBRATOR
K810964
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Dec 11, 1980
ALBUMIN/TOTAL PROTEIN STANDARDS
K802632
Gilford Diagnostics
Chemistry · 49d
Cleared Dec 11, 1980
BUN/GLUCOSE STANDARDS
K802633
Gilford Diagnostics
Chemistry · 49d
Cleared Dec 11, 1980
COMBUNED CALCIUM AND PHOSPHORUS STD.
K802824
Mallinckrodt Critical Care
Chemistry · 31d
Cleared Dec 11, 1980
COMBINED GLUCOSE AND BUN STANDARDS
K802825
Mallinckrodt Critical Care
Chemistry · 31d
Cleared Dec 10, 1980
CENTRIFICHEM COMB. SERUM-BASED CALIB.
K802741
Union Carbide Corp.
Chemistry · 37d
Cleared Jun 26, 1980
REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER
K801222
Simmler, Inc.
Chemistry · 34d
Cleared Apr 29, 1980
GAL-PUT CONTROLS, NORMAL&DEFICIENT
K800910
Sigma Chemical Co.
Chemistry · 8d
Cleared Jan 21, 1980
SODIUM/POTASSIUM (100/100 MEQ/E)
K800040
Gilford Diagnostics
Chemistry · 14d
Cleared Jan 21, 1980
SODIUM/POTASSIUM 140/5 MEQ/L)
K800041
Gilford Diagnostics
Chemistry · 14d
Cleared Jan 21, 1980
CESIUM DILUENT (1.5 MM/L)
K800043
Gilford Diagnostics
Chemistry · 14d
Cleared Dec 31, 1979
SERACON-SRI
K792485
Bhp Diagnostix, Inc.
Chemistry · 28d
Cleared Dec 31, 1979
SERACON-SRI (PROD. # D029
K792486
Bhp Diagnostix, Inc.
Chemistry · 28d
Cleared Dec 31, 1979
SERACON-SRII
K792487
Bhp Diagnostix, Inc.
Chemistry · 28d
Cleared Dec 06, 1979
PRINCIPAL ANALYTE REFERENCE SERUM
K792384
Beckman Instruments, Inc.
Chemistry · 10d
Cleared Nov 13, 1979
LANCER L-INA HUMAN REFERENCE SERUM
K792013
Sherwood Medical Industries
Immunology · 39d
Cleared Oct 17, 1979
CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD
K791874
Gilford Diagnostics
Chemistry · 26d
Cleared Oct 11, 1979
SERACON CAL D025
K791956
Bhp Diagnostix, Inc.
Chemistry · 10d
Cleared Sep 17, 1979
CALIBRATOR I
K791693
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
CALIBRATOR II
K791694
Hi Chem, Inc.
Chemistry · 48d
Cleared Feb 26, 1979
SERACON-N
K782039
Bhp Diagnostix, Inc.
Chemistry · 82d