The following data is part of a premarket notification filed by Coeur Laboratories, Inc. with the FDA for Capillary Tube, Blood Collection.
| Device ID | K885138 |
| 510k Number | K885138 |
| Device Name: | CAPILLARY TUBE, BLOOD COLLECTION |
| Classification | Tube, Collection, Capillary Blood |
| Applicant | COEUR LABORATORIES, INC. 5301 DEPATURE DR. Raleigh, NC 27604 |
| Contact | Teresa R Mccleery |
| Correspondent | Teresa R Mccleery COEUR LABORATORIES, INC. 5301 DEPATURE DR. Raleigh, NC 27604 |
| Product Code | GIO |
| CFR Regulation Number | 864.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-15 |
| Decision Date | 1989-02-07 |