The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Mini-tip Culturette.
| Device ID | K803298 |
| 510k Number | K803298 |
| Device Name: | MINI-TIP CULTURETTE |
| Classification | System, Transport, Aerobic |
| Applicant | MARION LABORATORIES, INC. 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 | 1980-12-30 |
| Decision Date | 1981-01-12 |