510(k) K873670
K873670 is an FDA 510(k) premarket notification submitted by Molecular Biosystems, Inc. for the device "SNAP CAMPYLOBACTOR DIAGNOSTIC KIT". The FDA issued a decision of Substantially Equivalent on June 8, 1988. The device falls under product code LQO (Dna-Reagents, Campylobacter Spp.), a Class I device regulated under 21 CFR 866.3110. Molecular Biosystems, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 1988
- Date Received
- September 11, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna-Reagents, Campylobacter Spp.
- Device Class
- Class I
- Regulation Number
- 866.3110
- Review Panel
- MI
- Submission Type