The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Vacutainer Rapid Serum Tube Blood Collection Tube, Model 368774.
| Device ID | K101502 |
| 510k Number | K101502 |
| Device Name: | BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BECTON DICKINSON & CO. 1 BECTON DRIVE, MC300 Franklin Lakes, NJ 07417 -1885 |
| Contact | Mary Anne Alsberge |
| Correspondent | Mary Anne Alsberge BECTON DICKINSON & CO. 1 BECTON DRIVE, MC300 Franklin Lakes, NJ 07417 -1885 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-01 |
| Decision Date | 2010-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903687744 | K101502 | 000 |
| 30859952006407 | K101502 | 000 |
| 30859952006094 | K101502 | 000 |
| 30859952006070 | K101502 | 000 |
| 30859952006063 | K101502 | 000 |
| 50859952006050 | K101502 | 000 |
| 30859952006032 | K101502 | 000 |
| 30859952006025 | K101502 | 000 |
| 30382903687740 | K101502 | 000 |