Safe-Tec Capillary Blood Collection Tube
FDA 510(k) K884623 · Safe-Tec Clinical Products, Inc.
510(k) numberK884623
Submission
- Device name
- Safe-Tec Capillary Blood Collection Tube
- Applicant
- Safe-Tec Clinical Products, Inc.
Ivyland, PA, US - Received
- November 4, 1988
- Decision date
- December 1, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GIO – Tube, Collection, Capillary Blood
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.6150
- Specialty
- Hematology
Other 510(k)s with product code GIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972969 | Quick-Draw Capillary Whole Blood Collection SystemGIO · Traditional | Innovative Medical Technologies, Inc. | 09/22/1997SE |
| K941291 | Monoject Samplette Separator TubeGIO · Traditional | Sherwood Medical Co. | 10/27/1994SE |
| K894851 | Tru-TraxGIO · Traditional | Humagen, Inc. | 09/29/1989SE |
| K885324 | Hema(Pro)Tec(Tion)GIO · Traditional | Medical Products Search, Inc. | 02/17/1989SE |
| K885138 | Capillary Tube, Blood CollectionGIO · Traditional | Coeur Laboratories, Inc. | 02/07/1989SE |
| K881262 | Caraway Tubes, Heparin and PlainGIO · Traditional | Helps Products, Inc. | 05/06/1988SE |
| K881187 | Natelson Tubes, Heparin and PlainGIO · Traditional | Helps Products, Inc. | 05/06/1988SE |
| K875061 | Monoject Samplette Amber Capillary Serum SeparatorGIO · Traditional | Sherwood Medical Co. | 01/12/1988SE |
| K873647 | Ventrescreen Capillary Blood Collection TubeGIO · Traditional | Ventrex Laboratories, Inc. | 10/20/1987SE |
| K850806 | Corning Blood Collection Capillary TubesGIO · Traditional | Corning Medical & Scientific | 03/25/1985SE |
More from Corning Medical & Scientific
| 510(k) | Device | Decision |
|---|---|---|
| K890109 | Safepette DispenserJKA · Traditional | 02/23/1989SE |
Questions and answers
When was Safe-Tec Capillary Blood Collection Tube cleared by the FDA?
Safe-Tec Capillary Blood Collection Tube (K884623) received a 510(k) decision of Substantially Equivalent on December 1, 1988, 27 days after the submission was received.
What is the product code of K884623?
The FDA product code is GIO – Tube, Collection, Capillary Blood, a Class I (low risk) device regulated under 21 CFR 864.6150.