The following data is part of a premarket notification filed by American Scientific Products with the FDA for Staphylococcus Latex Agglutination Kit.
| Device ID | K820683 |
| 510k Number | K820683 |
| Device Name: | STAPHYLOCOCCUS LATEX AGGLUTINATION KIT |
| Classification | Staphylococcus Aureus Somatic Antigens |
| Applicant | AMERICAN SCIENTIFIC PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LHT |
| CFR Regulation Number | 866.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-11 |
| Decision Date | 1982-04-14 |