The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Gono-pak W/thayer-martin Agar/gono-pak.
| Device ID | K843341 |
| 510k Number | K843341 |
| Device Name: | GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK |
| Classification | System, Transport, Aerobic |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JTW |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-27 |
| Decision Date | 1984-09-27 |