The following data is part of a premarket notification filed by Molecular Biosystems, Inc. with the FDA for Snap(r) Rotavirus Diagnostic Kit.
| Device ID | K873565 |
| 510k Number | K873565 |
| Device Name: | SNAP(R) ROTAVIRUS DIAGNOSTIC KIT |
| Classification | Device, Specimen Collection |
| Applicant | MOLECULAR BIOSYSTEMS, INC. 10030 BARNES CANYON RD. San Diego, CA 92121 |
| Contact | Peter J Westkaemper |
| Correspondent | Peter J Westkaemper MOLECULAR BIOSYSTEMS, INC. 10030 BARNES CANYON RD. San Diego, CA 92121 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-02 |
| Decision Date | 1988-05-13 |