GGK · Class I · 21 CFR 864.8540

FDA Product Code GGK: Products, Red-cell Lysing Products

Leading manufacturers include E K Ind., Inc., Connecticut Diagnostics, Ltd. and Hematology Marketing Assoc..

29
Total
29
Cleared
43d
Avg days
1976
Since

FDA 510(k) Cleared Products, Red-cell Lysing Products Devices (Product Code GGK)

29 devices
1–24 of 29
Cleared Nov 30, 1988
COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II
K883836
Coulter Immunology
Hematology · 79d
Cleared Oct 12, 1988
KVM HEMOGLOBIN LYSING REAGENT
K883991
Kvm Technologies, Inc.
Hematology · 22d
Cleared Oct 20, 1987
FISHER DIAGNOSTICS HEMATALL III LAS REAGENT
K874054
Fisher Scientific Co., LLC
Hematology · 15d
Cleared Sep 09, 1987
CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
K873348
Abbott Diagnostics
Hematology · 20d
Cleared Nov 06, 1986
PIASTRINIT
K863114
J. D. Assoc.
Hematology · 85d
Cleared Oct 03, 1986
HEMOLYSE
K863503
Reagent Laboratory, Inc.
Hematology · 24d
Cleared Mar 29, 1985
LASER-LYSE
K850097
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 29, 1985
NSI LYSING-D REAGENT -4000 ML
K850944
Nobel Scientific Industries, Inc.
Hematology · 22d
Cleared Sep 14, 1984
ACETIC ACID 1% V/V
K842938
E K Ind., Inc.
Hematology · 51d
Cleared Sep 12, 1984
ACETIC ACID, 5% V/V
K842935
E K Ind., Inc.
Hematology · 49d
Cleared Sep 12, 1984
ACETIC ACID, 3% V/V
K842936
E K Ind., Inc.
Hematology · 49d
Cleared Sep 12, 1984
ACETIC ACID 2% V/V
K842937
E K Ind., Inc.
Hematology · 49d
Cleared Jul 02, 1984
IDL-LYSING REAGENT
K842069
Interscience Diagnostics, Inc.
Hematology · 40d
Cleared May 31, 1984
LYSING & HEMOGLOBIN REAGENT
K841800
Reagent Laboratory, Inc.
Hematology · 43d
Cleared Mar 05, 1984
LYSE-TEC
K840289
Medilab Corp.
Hematology · 41d
Cleared Jan 30, 1984
THROMBO PLUS
K834527
W. Sarstedt, Inc.
Hematology · 40d
Cleared Nov 03, 1983
LYSING & HEMOGLOBIN S-REAGENT J & S
K833444
Jasins & Sayles Associates, Inc.
Hematology · 29d
Cleared Aug 12, 1983
LYSING REAGENT
K832182
Omega Medical Diagnostics
Hematology · 36d
Cleared Feb 28, 1983
LYSIS +
K830186
Hematology Marketing Assoc.
Pathology · 40d
Cleared Nov 08, 1982
RED CELL LYSING REAGENT 78N 1915-1
K822324
Interscience, Inc.
Hematology · 97d
Cleared Sep 17, 1982
CDL LYSING REAGENT
K822500
Connecticut Diagnostics, Ltd.
Hematology · 30d
Cleared Sep 17, 1982
CDL AUTO-LYSING REAGENT
K822504
Connecticut Diagnostics, Ltd.
Hematology · 29d
Cleared Oct 28, 1981
ELUAID
K812002
Ortho Diagnostic Systems, Inc.
Hematology · 106d
Cleared Dec 11, 1980
SERA-PAK TOTAL PROTEIN REAGENT
K802742
Miles Laboratories, Inc.
Chemistry · 38d

About Product Code GGK - Regulatory Context