Product Code: GIO FDA class 1 21 CFR 864.6150

Tube, Collection, Capillary Blood

Hematology

The Tube, Collection, Capillary Blood (product code GIO) is a small-bore glass or plastic tube used to collect blood samples obtained by fingerstick or heelstick for hematology and other laboratory analyses requiring small specimen volumes. 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 864.6150 in the Hematology specialty (HE), this device carries no special regulatory flags.

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FEI Numbers

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Basic Information

Product Code: GIO
Device Class: FDA class 1
Regulation Number: 864.6150
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 22 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K972969	QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM	Sep 22, 1997	Substantially Equivalent	Innovative Medical Technologies, Inc.
K941291	MONOJECT SAMPLETTE SEPARATOR TUBE	Oct 27, 1994	Substantially Equivalent	Sherwood Medical Co.
K894851	TRU-TRAX	Sep 29, 1989	Substantially Equivalent	Humagen, Inc.
K885324	HEMA(PRO)TEC(TION)	Feb 17, 1989	Substantially Equivalent	Medical Products Search, Inc.
K885138	CAPILLARY TUBE, BLOOD COLLECTION	Feb 07, 1989	Substantially Equivalent	Coeur Laboratories, Inc.
K884623	SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE	Dec 01, 1988	Substantially Equivalent	Safe-Tec Clinical Products, Inc.
K881262	CARAWAY TUBES, HEPARIN AND PLAIN	May 06, 1988	Substantially Equivalent	Helps Products, Inc.
K881187	NATELSON TUBES, HEPARIN AND PLAIN	May 06, 1988	Substantially Equivalent	Helps Products, Inc.
K875061	MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR	Jan 12, 1988	Substantially Equivalent	Sherwood Medical Co.
K873647	VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE	Oct 20, 1987	Substantially Equivalent	Ventrex Laboratories, Inc.
K850806	CORNING BLOOD COLLECTION CAPILLARY TUBES	Mar 25, 1985	Substantially Equivalent	Corning Medical & Scientific
K843608	CAPILLARY BLOOD COLLECTION TUBE	Nov 30, 1984	Substantially Equivalent	Medical Technomics, Ltd.
K843892	MICRO HEMATOCRIT CAPILLARY TUBES	Nov 13, 1984	Substantially Equivalent	Abco Dealers, Inc.
K843362	RINGCAPS	Sep 21, 1984	Substantially Equivalent	Medical Technomics, Ltd.
K843361	MINICAPS	Sep 21, 1984	Substantially Equivalent	Medical Technomics, Ltd.
K832578	MONOJET SAMPLETTE ADAPTERS	Aug 31, 1983	Substantially Equivalent	Sherwood Medical Co.
K812970	S/P CAPILLARY TUBES, HEPARINIZED (3A)	Nov 06, 1981	Substantially Equivalent	American Dade
K812969	S/P CAPILLARY TUBES, HEPARINIZED (2A)	Nov 06, 1981	Substantially Equivalent	American Dade
K812923	S/P SURE-CAP N	Nov 06, 1981	Substantially Equivalent	American Dade
K812922	S/P SURE-CAP C	Nov 06, 1981	Substantially Equivalent	American Dade
K812921	S/P SURE-CAP	Nov 06, 1981	Substantially Equivalent	American Dade
K770981	LANCER CAPILLARY BLOOD SERUM SEPARATOR	Jul 11, 1977	Substantially Equivalent	Sherwood Medical Industries