JIT · Class II · 21 CFR 862.1150

FDA Product Code JIT: Calibrator, Secondary

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

245
Total
245
Cleared
59d
Avg days
1976
Since
245 devices
169–192 of 245
Cleared May 26, 1987
PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR
K871765
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR
K871766
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
UREA N STANDARD SOLUTION CALIBRATOR
K871767
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
URIC ACID STANDARD SOLUTION CALIBRATOR
K871768
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared Mar 19, 1987
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR
K870673
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 28d
Cleared Aug 19, 1986
EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95
K862525
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Jul 01, 1986
CHOLESTEROL CALIBRATORS
K861314
Sigma Diagnostics, Inc.
Chemistry · 84d
Cleared Jul 12, 1985
CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET
K852461
Medical Analysis Systems, Inc.
Chemistry · 32d
Cleared May 31, 1985
DIRECT BILIRUBEN CALIBRATIONS
K852067
Data Medical Associates, Inc.
Chemistry · 21d
Cleared May 10, 1985
CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/
K851670
Medical Analysis Systems, Inc.
Chemistry · 17d
Cleared Dec 11, 1984
TRIGLYCERIDE CALIBRATOR
K844468
Sigma Diagnostics, Inc.
Chemistry · 22d
Cleared Sep 13, 1984
ROCHE STANDARDS FOR URIC ACID
K843112
Roche Diagnostic Systems, Inc.
Chemistry · 37d
Cleared Aug 17, 1984
ACTH STANDARD MATRIX
K842099
Diagnostic Systems Laboratories, Inc.
Chemistry · 84d
Cleared Apr 13, 1984
ALCOHOL & AMMONIA CALIBRATOR I
K840771
American Dade
Chemistry · 65d
Cleared Apr 13, 1984
ALCOHOL & AMMONIA CALIBRATOR II
K840772
American Dade
Chemistry · 65d
Cleared Apr 04, 1984
CARBON DIOXIDE CALIBRATOR I
K840774
American Dade
Chemistry · 56d
Cleared Apr 04, 1984
CARBON DIOXIDE CALIBRATOR II
K840775
American Dade
Chemistry · 56d
Cleared Mar 23, 1984
TRIGLYCERIDE AQUEOUS STANDARDS
K840218
Preventive Diagnostics Corp.
Chemistry · 64d
Cleared Jan 04, 1984
ACA THYROXINE UPTAKE CALIBRATOR
K833702
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 78d
Cleared Dec 27, 1983
ACA THYROXINE CALIBRATOR
K833700
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 70d
Cleared Aug 11, 1983
BILIRUBIN CALIBRATORS & CONTROL
K832094
Gilford Diagnostics
Chemistry · 44d
Cleared Oct 27, 1982
TRIGLYCERIDE CALIBRATOR
K822852
Harleco Diagnostics
Chemistry · 33d
Cleared Sep 21, 1982
SERA CHEM SMAC CALIBRATORS
K822496
Fisher Scientific Co., LLC
Chemistry · 34d
Cleared Sep 14, 1982
TOTAL PROTEIN STANDARD, #65074
K822475
Emd Chemicals, Inc.
Chemistry · 28d