Corning Blood Collection Capillary Tubes
FDA 510(k) K850806 · Corning Medical & Scientific
510(k) numberK850806
Submission
- Device name
- Corning Blood Collection Capillary Tubes
- Applicant
- Corning Medical & Scientific
Medfield, MA, US - Received
- February 27, 1985
- Decision date
- March 25, 1985
- 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 |
| K873647 | Ventrescreen Capillary Blood Collection TubeGIO · Traditional | Ventrex Laboratories, Inc. | 10/20/1987SE |
More from Ventrex Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K875122 | Disposable Sterile Syringe FiltersKET · Traditional | 01/12/1988SE |
| K872273 | Corning Easy Wash Elisa PlatesLIB · Traditional | 07/07/1987SE |
| K872076 | Corning Disposable Roller BottlesKJB · Traditional | 06/15/1987SE |
| K863789 | Corning Elisa PlatesLIB · Traditional | 10/03/1986SE |
| K854024 | Corning Magic Mab HCG RadioimmunoassayJHI · Traditional | 11/26/1985SE |
| K853634 | Corning Cell Wells-Multiple Well PlatesKIZ · Traditional | 09/16/1985SE |
| K851939 | Corning Certain -IseJIX · Traditional | 06/14/1985SE |
| K851329 | Magic Monoclonal Antibody Tsh(Mab Tsh)RadioimmunoaJLW · Traditional | 06/13/1985SE |
| K850617 | Corning 780 Fluorometer/DensitometerJQT · Traditional | 03/12/1985SE |
| K844671 | Corning Disposal Sterile Filter System-NylonKET · Traditional | 02/25/1985SE |
Questions and answers
When was Corning Blood Collection Capillary Tubes cleared by the FDA?
Corning Blood Collection Capillary Tubes (K850806) received a 510(k) decision of Substantially Equivalent on March 25, 1985, 26 days after the submission was received.
What is the product code of K850806?
The FDA product code is GIO – Tube, Collection, Capillary Blood, a Class I (low risk) device regulated under 21 CFR 864.6150.