The following data is part of a premarket notification filed by Bd Vacutainer Systems Preanalyical Solutions with the FDA for Bd Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341.
| Device ID | K030573 |
| 510k Number | K030573 |
| Device Name: | BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS 1 BECTON DR., BECTON BLDG. Franklin Lakes, NJ 07417 -1885 |
| Contact | M. Wendy Ballesteros |
| Correspondent | M. Wendy Ballesteros BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS 1 BECTON DR., BECTON BLDG. 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 | 2003-02-24 |
| Decision Date | 2003-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903686594 | K030573 | 000 |
| 50382903673242 | K030573 | 000 |
| 50382903673266 | K030573 | 000 |
| 50382903673358 | K030573 | 000 |
| 50382903673365 | K030573 | 000 |
| 50382903673389 | K030573 | 000 |
| 50382903673419 | K030573 | 000 |
| 50382903673426 | K030573 | 000 |
| 50382903673440 | K030573 | 000 |
| 50382903673525 | K030573 | 000 |
| 50382903686563 | K030573 | 000 |
| 50382903673235 | K030573 | 000 |