The following data is part of a premarket notification filed by Immuno-mycologics, Inc. with the FDA for Crag Lateral Flow Assay (lfa).
| Device ID | K112422 |
| 510k Number | K112422 |
| Device Name: | CRAG LATERAL FLOW ASSAY (LFA) |
| Classification | Antisera, Latex Agglutination, Cryptococcus Neoformans |
| Applicant | IMMUNO-MYCOLOGICS, INC. 2700 TECHNOLOGY PLACE Norman, OK 73071 |
| Contact | Sean K Bauman |
| Correspondent | Sean K Bauman IMMUNO-MYCOLOGICS, INC. 2700 TECHNOLOGY PLACE Norman, OK 73071 |
| Product Code | GMD |
| CFR Regulation Number | 866.3165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-23 |
| Decision Date | 2012-03-28 |
| Summary: | summary |