Product code GIO
- Device name
- Tube, Collection, Capillary Blood
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.6150
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972969 | QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM | Innovative Medical Technologies, Inc. | 1997-09-22 |
| K941291 | MONOJECT SAMPLETTE SEPARATOR TUBE | Sherwood Medical Co. | 1994-10-27 |
| K894851 | TRU-TRAX | Humagen, Inc. | 1989-09-29 |
| K885324 | HEMA(PRO)TEC(TION) | Medical Products Search, Inc. | 1989-02-17 |
| K885138 | CAPILLARY TUBE, BLOOD COLLECTION | Coeur Laboratories, Inc. | 1989-02-07 |
| K884623 | SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE | Safe-Tec Clinical Products, Inc. | 1988-12-01 |
| K881262 | CARAWAY TUBES, HEPARIN AND PLAIN | Helps Products, Inc. | 1988-05-06 |
| K881187 | NATELSON TUBES, HEPARIN AND PLAIN | Helps Products, Inc. | 1988-05-06 |
| K875061 | MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR | Sherwood Medical Co. | 1988-01-12 |
| K873647 | VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE | Ventrex Laboratories, Inc. | 1987-10-20 |
| K850806 | CORNING BLOOD COLLECTION CAPILLARY TUBES | Corning Medical & Scientific | 1985-03-25 |
| K843608 | CAPILLARY BLOOD COLLECTION TUBE | Medical Technomics, Ltd. | 1984-11-30 |
| K843892 | MICRO HEMATOCRIT CAPILLARY TUBES | Abco Dealers, Inc. | 1984-11-13 |
| K843362 | RINGCAPS | Medical Technomics, Ltd. | 1984-09-21 |
| K843361 | MINICAPS | Medical Technomics, Ltd. | 1984-09-21 |
| K832578 | MONOJET SAMPLETTE ADAPTERS | Sherwood Medical Co. | 1983-08-31 |
| K812970 | S/P CAPILLARY TUBES, HEPARINIZED (3A) | American Dade | 1981-11-06 |
| K812969 | S/P CAPILLARY TUBES, HEPARINIZED (2A) | American Dade | 1981-11-06 |
| K812923 | S/P SURE-CAP N | American Dade | 1981-11-06 |
| K812922 | S/P SURE-CAP C | American Dade | 1981-11-06 |
| K812921 | S/P SURE-CAP | American Dade | 1981-11-06 |
| K770981 | LANCER CAPILLARY BLOOD SERUM SEPARATOR | Sherwood Medical Industries | 1977-07-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00848530108113 | DIATUBE002 | SUNSET HEALTHCARE SOLUTIONS, INC. | 2025-12-23 |
| 00381934774015 | PTS Diagnostics Capillary Tubes | POLYMER TECHNOLOGY SYSTEMS, INC. | 2025-06-16 |
| 00850059420072 | MICROSAFE | DRUMMOND SCIENTIFIC COMPANY | 2024-05-17 |
| 00850059420065 | MICROSAFE | DRUMMOND SCIENTIFIC COMPANY | 2024-05-17 |
| 00850059420058 | MICROSAFE | DRUMMOND SCIENTIFIC COMPANY | 2024-05-17 |
| 00850059420027 | SAFECAP | DRUMMOND SCIENTIFIC COMPANY | 2024-05-17 |
| 00850059420010 | SAFECAP | DRUMMOND SCIENTIFIC COMPANY | 2024-05-17 |
| 00850059420003 | SAFECAP | DRUMMOND SCIENTIFIC COMPANY | 2024-05-17 |
| 00840095644983 | Globe Scientific | GLOBE SCIENTIFIC INC. | 2023-07-03 |
| 10643351000274 | SAFE-T-FILL® | Ram Scientific, Inc | 2022-10-01 |
| 10643351000267 | SAFE-T-FILL® | Ram Scientific, Inc | 2022-10-01 |
| 10643351000281 | SAFE-T-FILL® | Ram Scientific, Inc | 2022-10-01 |
| 10643351000298 | SAFE-T-FILL® | Ram Scientific, Inc | 2022-10-01 |
| 10643351000304 | SAFE-T-FILL® | Ram Scientific, Inc | 2022-10-01 |
| 10643351000311 | SAFE-T-FILL® | Ram Scientific, Inc | 2022-10-01 |
| 10643351000328 | SAFE-T-FILL® | Ram Scientific, Inc | 2022-10-01 |
| 29120017578714 | MiniCollect | Greiner Bio-One GmbH | 2020-09-23 |
| 29120017570992 | MiniCollect | Greiner Bio-One GmbH | 2020-09-23 |
| 29120017571005 | MiniCollect | Greiner Bio-One GmbH | 2020-09-23 |
| 29120017578691 | MiniCollect | Greiner Bio-One GmbH | 2020-09-23 |
| 00630414606460 | epoc Host2 | Epocal Inc | 2020-07-15 |
| 00630414202433 | Luer Capillary | Siemens Healthcare Diagnostics Inc. | 2020-07-09 |
| 00612479226746 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-04-20 |
| 00612479226753 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-04-20 |
| 00612479203709 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-04-20 |
| 00612479203693 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-04-20 |
| 00612479203686 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-04-20 |
| 00612479203679 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-04-20 |
| 10857182006088 | QUICK-DRAW PLAIN ADAPTER | Innovative Medical Technologies, Inc. | 2016-08-05 |
| 30857182006099 | QUICK-DRAW HEPARIN ADAPTER | Innovative Medical Technologies, Inc. | 2016-08-05 |