The following data is part of a premarket notification filed by Cambridge Bioscience Corp. with the FDA for Rotaclone Rotavirus Diagnostic Kit.
| Device ID | K852969 |
| 510k Number | K852969 |
| Device Name: | ROTACLONE ROTAVIRUS DIAGNOSTIC KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | CAMBRIDGE BIOSCIENCE CORP. 35 SOUTH ST. Hopkinton, MA 01748 |
| Contact | Rod N Raynovich |
| Correspondent | Rod N Raynovich CAMBRIDGE BIOSCIENCE CORP. 35 SOUTH ST. Hopkinton, MA 01748 |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-15 |
| Decision Date | 1985-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101700 | K852969 | 000 |