The following data is part of a premarket notification filed by Remel Co. with the FDA for Bacti-swab Dry.
| Device ID | K013711 |
| 510k Number | K013711 |
| Device Name: | BACTI-SWAB DRY |
| Classification | Device, Specimen Collection |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Robert E Booth |
| Correspondent | Robert E Booth REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-07 |
| Decision Date | 2001-11-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838018244 | K013711 | 000 |
| 00848838018220 | K013711 | 000 |
| 00848838018206 | K013711 | 000 |
| 00848838018190 | K013711 | 000 |