The following data is part of a premarket notification filed by Molecular Biosystems, Inc. with the FDA for Snap Campylobactor Diagnostic Kit.
| Device ID | K873670 |
| 510k Number | K873670 |
| Device Name: | SNAP CAMPYLOBACTOR DIAGNOSTIC KIT |
| Classification | Dna-reagents, Campylobacter Spp. |
| Applicant | MOLECULAR BIOSYSTEMS, INC. 10030 BARNES CANYON RD. San Diego, CA 92121 |
| Contact | Peter Westkaemper |
| Correspondent | Peter Westkaemper MOLECULAR BIOSYSTEMS, INC. 10030 BARNES CANYON RD. San Diego, CA 92121 |
| Product Code | LQO |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-11 |
| Decision Date | 1988-06-08 |