The following data is part of a premarket notification filed by Bioaccess, Inc. with the FDA for Kit, Bone Marrow Collection.
| Device ID | BK970035 |
| 510k Number | BK970035 |
| Device Name: | Kit, Bone Marrow Collection |
| Classification | Bone Marrow Collection/transfusion Kit |
| Applicant | BioAccess, Inc. 8400 Cedar Street Silver Spring, MD 20910 US |
| Product Code | LWE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-29 |
| Decision Date | 1998-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M791MH21500 | BK970035 | 0 |