The following data is part of a premarket notification filed by Remel Co. with the FDA for Bacti-swab.
| Device ID | K910180 |
| 510k Number | K910180 |
| Device Name: | BACTI-SWAB |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Ann Silvius |
| Correspondent | Ann Silvius REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-15 |
| Decision Date | 1991-05-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BACTI-SWAB 76447402 2717516 Live/Registered |
Remel Inc. 2002-09-06 |