GIF · Class I · 21 CFR 864.8200

FDA Product Code GIF: Diluent, Blood Cell

Leading manufacturers include Nobel Scientific Industries, Inc., Toa Medical Electronics USA, Inc. and Abbott Diagnostics.

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 Jul 12, 1988
SYSMEX QUICKLYSER-II (QLS-200A)
K882267
Toa Medical Electronics USA, Inc.
Hematology · 42d
Cleared Mar 31, 1988
CELL-DYN ISOTONIC DILUENT
K881130
Abbott Diagnostics
Hematology · 15d
Cleared Sep 09, 1987
CELL-DYN DIFF. SCREEN ISOTONIC DILUENT
K873347
Abbott Diagnostics
Hematology · 20d
Cleared Apr 01, 1985
SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-
K850239
Toa Medical Electronics USA, Inc.
Hematology · 69d
Cleared Mar 05, 1985
NSI ELT-D DILUTING FLUID 4000ML
K844782
Nobel Scientific Industries, Inc.
Hematology · 85d
Cleared Sep 07, 1984
HAYEM DILUTING FLUID
K842929
E K Ind., Inc.
Hematology · 44d
Cleared May 31, 1984
CYANOMETHEMOGLOBIN REAGENT
K841799
Reagent Laboratory, Inc.
Hematology · 43d
Cleared Mar 05, 1984
UNITIZED HEMATOLOGY SET 65132/93
K840477
Emd Chemicals, Inc.
Hematology · 31d
Cleared Feb 17, 1984
QUICK-COUNT HEMATOLOGY REAGENT KIT
K833972
Seragen Diagnostics, Inc.
Hematology · 93d
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 Aug 12, 1980
NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA
K801346
Nobel Scientific Industries, Inc.
Hematology · 64d
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

About Product Code GIF - Regulatory Context