GIF · Class I · 21 CFR 864.8200

FDA Product Code GIF: Diluent, Blood Cell

Leading manufacturers include Scientific Distributors, Inc., Hematology Marketing Assoc. and Nobel Scientific Industries, Inc..

38
Total
38
Cleared
46d
Avg days
1976
Since
38 devices
25–38 of 38
Cleared Oct 18, 1982
BLOOD CELL DILUENT 78N 1913
K822325
Interscience, Inc.
Hematology · 76d
Cleared Sep 17, 1982
CDL ISOTONIC DILUENT
K822501
Connecticut Diagnostics, Ltd.
Hematology · 30d
Cleared Jun 24, 1982
REAGENT FOR COULTER COUNTER MODEL 5+11
K821683
Fisher Scientific Co., LLC
Hematology · 16d
Cleared Sep 16, 1981
CRYOSAN NORMAL SALINE
K812309
Cryosan, Inc.
Chemistry · 30d
Cleared Aug 14, 1980
MODIFIED BLOOD CELL COUNTING & LYSING
K801357
Coulter Electronics, Inc.
Hematology · 66d
Cleared Aug 12, 1980
NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA
K801346
Nobel Scientific Industries, Inc.
Hematology · 64d
Cleared Apr 04, 1979
ISOTONIC DILUENT
K790442
Royco Instruments
Hematology · 28d
Cleared Feb 15, 1979
DILUENT, CELLENT BLOOD
K790028
Sysmex Corp.
Hematology · 43d
Cleared Jun 28, 1978
ISOTONIC DILUENT
K781008
Mallinckrodt Critical Care
Hematology · 9d
Cleared Jun 14, 1978
ISOTONIC BUFFERED SALINE
K780830
Harleco
Hematology · 26d
Cleared Oct 07, 1977
AZIDE FREE BLOOD DILUTING REAGENT
K771787
J.T. Baker Chemical Co.
Hematology · 17d
Cleared Jul 20, 1976
AUTO CELL DILUENT
K760124
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 22d
Cleared Jul 20, 1976
SALINE, ISOTONIC BUFFERED, AZIDE-FREE
K760129
Harleco
Hematology · 22d