GIF · Class I · 21 CFR 864.8200

FDA Product Code GIF: Diluent, Blood Cell

Leading manufacturers include Harleco, Bd Becton Dickinson Vacutainer Systems Preanalytic and J.T. Baker Chemical Co..

38
Total
38
Cleared
46d
Avg days
1976
Since

FDA 510(k) Cleared Diluent, Blood Cell Devices (Product Code GIF)

38 devices
1–24 of 38
Cleared Jul 25, 1988
HYCEL QUICK-LYSING HEMOGLOBIN REAGENT
K882490
R&D Systems, Inc.
Hematology · 39d
Cleared Sep 07, 1984
HAYEM DILUTING FLUID
K842929
E K Ind., Inc.
Hematology · 44d
Cleared Mar 05, 1984
UNITIZED HEMATOLOGY SET 65132/93
K840477
Emd Chemicals, Inc.
Hematology · 31d
Cleared Jun 24, 1982
REAGENT FOR COULTER COUNTER MODEL 5+11
K821683
Fisher Scientific Co., LLC
Hematology · 16d
Cleared Aug 14, 1980
MODIFIED BLOOD CELL COUNTING & LYSING
K801357
Coulter Electronics, Inc.
Hematology · 66d
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

About Product Code GIF - Regulatory Context