510(k) BK970035
- Device
- Kit, Bone Marrow Collection
- Applicant
- BioAccess, Inc.
- 510(k) number
- BK970035
- Product code
- LWE
- Decision
- Substantially Equivalent (SE)
- Decision date
- 1998-12-23
- Date received
- 1997-08-29
- Regulation
- 510(k) Premarket Notification
- Classification name
- Bone Marrow Collection/transfusion Kit
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Other 510(k) Records For Product Code LWE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952350 | JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) | Promedical , Ltd. | 1995-07-17 |
| K913306 | BONE-TEMNO/STERNUM-TEMNO | Proact, Ltd. | 1991-11-01 |
| K871198 | BONE MARROW COLLECTION KIT AND STAND | Baxter Healthcare Corp | 1987-11-06 |
Legacy Summary#
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FDA Review#
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