The following data is part of a premarket notification filed by Litton Bionetics with the FDA for Rotavirus Bio-enzabead Screen Kit.
| Device ID | K834443 |
| 510k Number | K834443 |
| Device Name: | ROTAVIRUS BIO-ENZABEAD SCREEN KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | LITTON BIONETICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-16 |
| Decision Date | 1984-03-16 |