The following data is part of a premarket notification filed by Magnolia Medical Technologies with the FDA for Steripath Micro Blood Collection System.
| Device ID | K222299 |
| 510k Number | K222299 |
| Device Name: | Steripath Micro Blood Collection System |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Magnolia Medical Technologies 200 West Mercer Street, Suite 500 Seattle, WA 98119 |
| Contact | Greg Bullington |
| Correspondent | Donna Matuizek Magnolia Medical Technologies 200 West Mercer Street, Suite 500 Seattle, WA 98119 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-01 |
| Decision Date | 2022-11-30 |