The following data is part of a premarket notification filed by Immucell Corp. with the FDA for Immustaph Latex Agglutination Kit.
| Device ID | K842709 |
| 510k Number | K842709 |
| Device Name: | IMMUSTAPH LATEX AGGLUTINATION KIT |
| Classification | Staphylococcus Aureus Protein A Insoluble |
| Applicant | IMMUCELL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LHJ |
| CFR Regulation Number | 866.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-12 |
| Decision Date | 1984-08-03 |