Product Code: GGK FDA class 1 21 CFR 864.8540

Products, Red-Cell Lysing Products

Hematology

Red-Cell Lysing Products (product code GGK) are hematology reagents used to selectively destroy red blood cells in blood samples, facilitating the isolation and counting of white blood cells or other cellular components in automated or manual analysis. This device is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 864.8540 in the Hematology specialty (HE), this device carries no special regulatory flags.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code GGK in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: GGK
Device Class: FDA class 1
Regulation Number: 864.8540
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 29 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K883836	COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II	Nov 30, 1988	Substantially Equivalent	Coulter Immunology
K883991	KVM HEMOGLOBIN LYSING REAGENT	Oct 12, 1988	Substantially Equivalent	Kvm Technologies, Inc.
K874054	FISHER DIAGNOSTICS HEMATALL III LAS REAGENT	Oct 20, 1987	Substantially Equivalent	Fisher Scientific Co., LLC
K873348	CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.	Sep 09, 1987	Substantially Equivalent	Abbott Diagnostics
K863114	PIASTRINIT	Nov 06, 1986	Substantially Equivalent	J. D. Assoc.
K863503	HEMOLYSE	Oct 03, 1986	Substantially Equivalent	Reagent Laboratory, Inc.
K850944	NSI LYSING-D REAGENT -4000 ML	Mar 29, 1985	Substantially Equivalent	Nobel Scientific Industries, Inc.
K850097	LASER-LYSE	Mar 29, 1985	Substantially Equivalent	Hematology Marketing Assoc.
K842938	ACETIC ACID 1% V/V	Sep 14, 1984	Substantially Equivalent	E K Ind., Inc.
K842937	ACETIC ACID 2% V/V	Sep 12, 1984	Substantially Equivalent	E K Ind., Inc.
K842936	ACETIC ACID, 3% V/V	Sep 12, 1984	Substantially Equivalent	E K Ind., Inc.
K842935	ACETIC ACID, 5% V/V	Sep 12, 1984	Substantially Equivalent	E K Ind., Inc.
K842069	IDL-LYSING REAGENT	Jul 02, 1984	Substantially Equivalent	Interscience Diagnostics, Inc.
K841800	LYSING & HEMOGLOBIN REAGENT	May 31, 1984	Substantially Equivalent	Reagent Laboratory, Inc.
K840289	LYSE-TEC	Mar 05, 1984	Substantially Equivalent	Medilab Corp.
K834527	THROMBO PLUS	Jan 30, 1984	Substantially Equivalent	W. Sarstedt, Inc.
K833444	LYSING & HEMOGLOBIN S-REAGENT J & S	Nov 03, 1983	Substantially Equivalent	Jasins & Sayles Associates, Inc.
K832182	LYSING REAGENT	Aug 12, 1983	Substantially Equivalent	Omega Medical Diagnostics
K830186	LYSIS +	Feb 28, 1983	Substantially Equivalent	Hematology Marketing Assoc.
K822324	RED CELL LYSING REAGENT 78N 1915-1	Nov 08, 1982	Substantially Equivalent	Interscience, Inc.
K822504	CDL AUTO-LYSING REAGENT	Sep 17, 1982	Substantially Equivalent	Connecticut Diagnostics, Ltd.
K822500	CDL LYSING REAGENT	Sep 17, 1982	Substantially Equivalent	Connecticut Diagnostics, Ltd.
K812002	ELUAID	Oct 28, 1981	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K802742	SERA-PAK TOTAL PROTEIN REAGENT	Dec 11, 1980	Substantially Equivalent	Miles Laboratories, Inc.
K790029	FLUID, RHEMOX W LYSING	Feb 26, 1979	Substantially Equivalent	Sysmex Corp.
K782098	REAGENT, LYSING AND HEMOGLOBIN	Jan 17, 1979	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K781121	HEMOLYSE	Aug 14, 1978	Substantially Equivalent	Electrophoresis Corp. of America
K771788	CYMET-AUTOMATED	Oct 07, 1977	Substantially Equivalent	J.T. Baker Chemical Co.
K761182	ISOTONIC DILUENT AF	Dec 09, 1976	Substantially Equivalent	Central Labs. Assoc. MD Pathologists