GIF · Class I · 21 CFR 864.8200

FDA Product Code GIF: Diluent, Blood Cell

Leading manufacturers include Scientific Distributors, Inc., Hematology Marketing Assoc. and Kvm Technologies, Inc..

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 Oct 12, 1988
KVM ISOTONIC FLUSH SOLUTION
K883989
Kvm Technologies, Inc.
Hematology · 22d
Cleared Oct 12, 1988
KVM ISOTONIC DILUENT
K883990
Kvm Technologies, Inc.
Hematology · 22d
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 Jul 30, 1985
OSMOCEL 3
K851843
Hematology Marketing Assoc.
Hematology · 95d
Cleared Jul 05, 1985
DASS PACK
K851280
Dass, Inc.
Hematology · 95d
Cleared Jul 05, 1985
SDI PREPAX DILUKIT M.
K851320
Scientific Distributors, Inc.
Hematology · 94d
Cleared Apr 01, 1985
SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-
K850239
Toa Medical Electronics USA, Inc.
Hematology · 69d
Cleared Mar 29, 1985
LASER-DIL
K850095
Hematology Marketing Assoc.
Hematology · 77d
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 Jul 02, 1984
IDI ISOTONIC DILUENT
K842068
Interscience Diagnostics, Inc.
Hematology · 40d
Cleared May 31, 1984
CYANOMETHEMOGLOBIN REAGENT
K841799
Reagent Laboratory, Inc.
Hematology · 43d
Cleared Mar 05, 1984
SDI PREPAX DILUKIT HW
K840041
Scientific Distributors, Inc.
Hematology · 59d
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 Feb 10, 1984
PREPAX DILUKIT PLUS
K840038
Scientific Distributors, Inc.
Hematology · 36d
Cleared Feb 10, 1984
SDI PREPAX DILUKIT CT
K840043
Scientific Distributors, Inc.
Hematology · 35d
Cleared Nov 03, 1983
ISOTONIC BLOOD CELL DILUENT J & S
K833443
Jasins & Sayles Associates, Inc.
Hematology · 29d
Cleared Oct 20, 1983
ATAC 4700 HEMATOLOGY CELL COUNTER
K832116
Turpen Laboratory Systems, Inc.
Hematology · 112d
Cleared Jun 16, 1983
DILUENT
K831617
Omega Medical Diagnostics
Hematology · 28d
Cleared Mar 01, 1983
OSMOCEL +
K830188
Hematology Marketing Assoc.
Hematology · 41d

About Product Code GIF - Regulatory Context