GIO · Tube, Collection, Capillary Blood
Hematology · 21 CFR 864.6150 · Class 1
Overview
| Product Code | GIO |
|---|---|
| Device Name | Tube, Collection, Capillary Blood |
| Regulation | 21 CFR 864.6150 |
| Device Class | Class 1 |
| Review Panel | Hematology |
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 | QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM | Innovative Medical Technologies, Inc. | Sep 22, 1997 | SESE |
| K941291 | MONOJECT SAMPLETTE SEPARATOR TUBE | Sherwood Medical Co. | Oct 27, 1994 | SESE |
| K894851 | TRU-TRAX | Humagen, Inc. | Sep 29, 1989 | SESE |
| K885324 | HEMA(PRO)TEC(TION) | Medical Products Search, Inc. | Feb 17, 1989 | SESE |
| K885138 | CAPILLARY TUBE, BLOOD COLLECTION | Coeur Laboratories, Inc. | Feb 7, 1989 | SESE |
| K884623 | SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE | Safe-Tec Clinical Products, Inc. | Dec 1, 1988 | SESE |
| K881262 | CARAWAY TUBES, HEPARIN AND PLAIN | Helps Products, Inc. | May 6, 1988 | SESE |
| K881187 | NATELSON TUBES, HEPARIN AND PLAIN | Helps Products, Inc. | May 6, 1988 | SESE |
| K875061 | MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR | Sherwood Medical Co. | Jan 12, 1988 | SESE |
| K873647 | VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE | Ventrex Laboratories, Inc. | Oct 20, 1987 | SESE |
| K850806 | CORNING BLOOD COLLECTION CAPILLARY TUBES | Corning Medical & Scientific | Mar 25, 1985 | SESE |
| K843608 | CAPILLARY BLOOD COLLECTION TUBE | Medical Technomics, Ltd. | Nov 30, 1984 | SESE |
| K843892 | MICRO HEMATOCRIT CAPILLARY TUBES | Abco Dealers, Inc. | Nov 13, 1984 | SESE |
| K843362 | RINGCAPS | Medical Technomics, Ltd. | Sep 21, 1984 | SESE |
| K843361 | MINICAPS | Medical Technomics, Ltd. | Sep 21, 1984 | SESE |
| K832578 | MONOJET SAMPLETTE ADAPTERS | Sherwood Medical Co. | Aug 31, 1983 | SESE |
| K812970 | S/P CAPILLARY TUBES, HEPARINIZED (3A) | American Dade | Nov 6, 1981 | SESE |
| K812969 | S/P CAPILLARY TUBES, HEPARINIZED (2A) | American Dade | Nov 6, 1981 | SESE |
| K812923 | S/P SURE-CAP N | American Dade | Nov 6, 1981 | SESE |
| K812922 | 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
