The following data is part of a premarket notification filed by Remel Co. with the FDA for Nitrate Swab-rapid Test.
| Device ID | K800803 |
| 510k Number | K800803 |
| Device Name: | NITRATE SWAB-RAPID TEST |
| Classification | Kit, Identification, Yeast |
| Applicant | REMEL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JXB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-10 |
| Decision Date | 1980-07-08 |