The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Vacutainer Brand Safety-lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set.
| Device ID | K980414 |
| 510k Number | K980414 |
| Device Name: | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | John Schalago |
| Correspondent | John Schalago BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-03 |
| Decision Date | 1998-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903672986 | K980414 | 000 |
| 50382903672887 | K980414 | 000 |
| 50382903686549 | K980414 | 000 |
| 00382903672813 | K980414 | 000 |
| 00382903672851 | K980414 | 000 |
| 00382903672929 | K980414 | 000 |
| 00382903672943 | K980414 | 000 |
| 00382903672967 | K980414 | 000 |
| 00382903672974 | K980414 | 000 |
| 00382903672981 | K980414 | 000 |
| 00382903686520 | K980414 | 000 |
| 00382903672837 | K980414 | 000 |
| 00382903672875 | K980414 | 000 |
| 00382903686537 | K980414 | 000 |
| 50382903672962 | K980414 | 000 |
| 50382903672979 | K980414 | 000 |
| 50382903686556 | K980414 | 000 |