510(k) K894712
K894712 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION". The FDA issued a decision of Substantially Equivalent on November 14, 1989. The device falls under product code LQO (Dna-Reagents, Campylobacter Spp.), a Class I device regulated under 21 CFR 866.3110. Gen-Probe, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 1989
- Date Received
- July 26, 1989
- 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