Capillary Tube, Blood Collection
FDA 510(k) K885138 · Coeur Laboratories, Inc.
510(k) numberK885138
Submission
- Device name
- Capillary Tube, Blood Collection
- Applicant
- Coeur Laboratories, Inc.
Raleigh, NC, US - Received
- December 15, 1988
- Decision date
- February 7, 1989
- 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 |
| 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 |
| K850806 | Corning Blood Collection Capillary TubesGIO · Traditional | Corning Medical & Scientific | 03/25/1985SE |
More from Corning Medical & Scientific
| 510(k) | Device | Decision |
|---|---|---|
| K971712 | Coeur 130 ML Angiographic SyringeDXT · Traditional | 10/08/1997SE |
| K965214 | Coeur Front Load Injector Retrofit Kit (C859-0002)DTX · Traditional | 03/28/1997SE |
| K960965 | Front Load Injector Turret Model 859-0001/200 ML Front Load Syringe Model 853-0211DXT · Traditional | 09/12/1996SE |
| K890292 | PCA-10, 10CC Disp. Angiography Control SyringeDXT · Traditional | 06/22/1989SE |
| K885202 | 16 Long Catheter W/Adapter, 14 FR and 12 FRKOD · Traditional | 01/31/1989SE |
| K881646 | Urological CatheterKOD · Traditional | 06/16/1988SE |
| K874579 | Coeur Control SyringeFMF · Traditional | 01/19/1988SE |
| K873597 | Tubing, PolyethyleneDXT · Traditional | 11/12/1987SE |
| K823920 | Coeurlock Sterile Dispos. AngiographicDXT · Traditional | 02/18/1983SE |
Questions and answers
When was Capillary Tube, Blood Collection cleared by the FDA?
Capillary Tube, Blood Collection (K885138) received a 510(k) decision of Substantially Equivalent on February 7, 1989, 54 days after the submission was received.
What is the product code of K885138?
The FDA product code is GIO – Tube, Collection, Capillary Blood, a Class I (low risk) device regulated under 21 CFR 864.6150.