The following data is part of a premarket notification filed by Immuno-mycologics, Inc. with the FDA for La-staph Identification System.
| Device ID | K831918 |
| 510k Number | K831918 |
| Device Name: | LA-STAPH IDENTIFICATION SYSTEM |
| Classification | Kit, Screening, Staphylococcus Aureus |
| Applicant | IMMUNO-MYCOLOGICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JWX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-08 |
| Decision Date | 1983-06-08 |