Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart G — Manual Hematology Devices](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices) → [21 CFR 864.6150](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6150) → GIO — Tube, Collection, Capillary Blood # GIO · Tube, Collection, Capillary Blood _Hematology · 21 CFR 864.6150 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO ## Overview - **Product Code:** GIO - **Device Name:** Tube, Collection, Capillary Blood - **Regulation:** [21 CFR 864.6150](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6150) - **Device Class:** 1 - **Review Panel:** [Hematology](/submissions/HE) ## Identification A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9. ## Recent Cleared Devices (20 of 22) Showing 20 most recent of 22 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K972969](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K972969.md) | QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM | Innovative Medical Technologies, Inc. | Sep 22, 1997 | SESE | | [K941291](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K941291.md) | MONOJECT SAMPLETTE SEPARATOR TUBE | Sherwood Medical Co. | Oct 27, 1994 | SESE | | [K894851](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K894851.md) | TRU-TRAX | Humagen, Inc. | Sep 29, 1989 | SESE | | [K885324](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K885324.md) | HEMA(PRO)TEC(TION) | Medical Products Search, Inc. | Feb 17, 1989 | SESE | | [K885138](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K885138.md) | CAPILLARY TUBE, BLOOD COLLECTION | Coeur Laboratories, Inc. | Feb 7, 1989 | SESE | | [K884623](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K884623.md) | SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE | Safe-Tec Clinical Products, Inc. | Dec 1, 1988 | SESE | | [K881262](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K881262.md) | CARAWAY TUBES, HEPARIN AND PLAIN | Helps Products, Inc. | May 6, 1988 | SESE | | [K881187](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K881187.md) | NATELSON TUBES, HEPARIN AND PLAIN | Helps Products, Inc. | May 6, 1988 | SESE | | [K875061](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K875061.md) | MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR | Sherwood Medical Co. | Jan 12, 1988 | SESE | | [K873647](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K873647.md) | VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE | Ventrex Laboratories, Inc. | Oct 20, 1987 | SESE | | [K850806](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K850806.md) | CORNING BLOOD COLLECTION CAPILLARY TUBES | Corning Medical & Scientific | Mar 25, 1985 | SESE | | [K843608](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K843608.md) | CAPILLARY BLOOD COLLECTION TUBE | Medical Technomics, Ltd. | Nov 30, 1984 | SESE | | [K843892](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K843892.md) | MICRO HEMATOCRIT CAPILLARY TUBES | Abco Dealers, Inc. | Nov 13, 1984 | SESE | | [K843362](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K843362.md) | RINGCAPS | Medical Technomics, Ltd. | Sep 21, 1984 | SESE | | [K843361](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K843361.md) | MINICAPS | Medical Technomics, Ltd. | Sep 21, 1984 | SESE | | [K832578](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K832578.md) | MONOJET SAMPLETTE ADAPTERS | Sherwood Medical Co. | Aug 31, 1983 | SESE | | [K812970](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K812970.md) | S/P CAPILLARY TUBES, HEPARINIZED (3A) | American Dade | Nov 6, 1981 | SESE | | [K812969](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K812969.md) | S/P CAPILLARY TUBES, HEPARINIZED (2A) | American Dade | Nov 6, 1981 | SESE | | [K812923](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K812923.md) | S/P SURE-CAP N | American Dade | Nov 6, 1981 | SESE | | [K812922](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K812922.md) | S/P SURE-CAP C | American Dade | Nov 6, 1981 | SESE | ## Top Applicants - American Dade — 5 clearances - Medical Technomics, Ltd. — 3 clearances - Sherwood Medical Co. — 3 clearances - Helps Products, Inc. — 2 clearances - Abco Dealers, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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