The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Microtainer Brand Tube With Edta.
| Device ID | K931368 |
| 510k Number | K931368 |
| Device Name: | MICROTAINER BRAND TUBE WITH EDTA |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Russell Arnsberger |
| Correspondent | Russell Arnsberger 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 | 1993-03-17 |
| Decision Date | 1993-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903659765 | K931368 | 000 |