The following data is part of a premarket notification filed by American Scientific Products with the FDA for Cryptococcal Antigen Latex Aggluti.
| Device ID | K812188 |
| 510k Number | K812188 |
| Device Name: | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI |
| Classification | Antisera, Latex Agglutination, Cryptococcus Neoformans |
| Applicant | AMERICAN SCIENTIFIC PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMD |
| CFR Regulation Number | 866.3165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-03 |
| Decision Date | 1981-08-31 |