GGK · Class I · 21 CFR 864.8540

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

Leading manufacturers include E K Ind., Inc., Reagent Laboratory, Inc. and J.T. Baker Chemical Co..

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 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
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 May 31, 1984
LYSING & HEMOGLOBIN REAGENT
K841800
Reagent Laboratory, Inc.
Hematology · 43d
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
Cleared Feb 26, 1979
FLUID, RHEMOX W LYSING
K790029
Sysmex Corp.
Hematology · 54d
Cleared Jan 17, 1979
REAGENT, LYSING AND HEMOGLOBIN
K782098
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 30d
Cleared Aug 14, 1978
HEMOLYSE
K781121
Electrophoresis Corp. of America
Hematology · 42d
Cleared Oct 07, 1977
CYMET-AUTOMATED
K771788
J.T. Baker Chemical Co.
Hematology · 17d

About Product Code GGK - Regulatory Context