Ventrescreen Capillary Blood Collection Tube
FDA 510(k) K873647 · Ventrex Laboratories, Inc.
510(k) numberK873647
Submission
- Device name
- Ventrescreen Capillary Blood Collection Tube
- Applicant
- Ventrex Laboratories, Inc.
Portland, ME, US - Received
- September 9, 1987
- Decision date
- October 20, 1987
- 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 |
| K884623 | Safe-Tec Capillary Blood Collection TubeGIO · Traditional | Safe-Tec Clinical Products, Inc. | 12/01/1988SE |
| 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 |
| K850806 | Corning Blood Collection Capillary TubesGIO · Traditional | Corning Medical & Scientific | 03/25/1985SE |
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|---|---|---|
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| K913833 | Ventrex Allergen DiscDHB · Traditional | 02/21/1992SE |
| K913434 | Ventrex Coated Tube Intact PTHCEW · Traditional | 10/25/1991SE |
| K905612 | Ventrex Coated Tube Ige RadioimmunoassayDGC · Traditional | 02/21/1991SE |
| K905636 | Ventrex Coated Tube Ige Enzyme ImmunoassayDHB · Traditional | 02/07/1991SE |
| K905247 | SHBG Irma KitCDZ · Traditional | 01/17/1991SE |
| K904330 | Turbo-Rast Specific Ige AssayDHB · Traditional | 12/07/1990SE |
| K903000 | Turbo-Rast Specific Ige AssayJHR · Traditional | 07/31/1990SE |
| K897083 | Ventresign Strep a TestGTZ · Traditional | 01/22/1990SE |
| K895649 | Coated Tube High Sensitivity TSH 200 Uiu/Ml Stan.JIT · Traditional | 01/18/1990SE |
Questions and answers
When was Ventrescreen Capillary Blood Collection Tube cleared by the FDA?
Ventrescreen Capillary Blood Collection Tube (K873647) received a 510(k) decision of Substantially Equivalent on October 20, 1987, 41 days after the submission was received.
What is the product code of K873647?
The FDA product code is GIO – Tube, Collection, Capillary Blood, a Class I (low risk) device regulated under 21 CFR 864.6150.