510(k) K901397
K901397 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.". The FDA issued a decision of Substantially Equivalent on June 20, 1990. The device falls under product code MCC (Dna-Probe, Haemophilus Spp.), a Class II device regulated under 21 CFR 866.3300. Gen-Probe, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 1990
- Date Received
- March 26, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna-Probe, Haemophilus Spp.
- Device Class
- Class II
- Regulation Number
- 866.3300
- Review Panel
- MI
- Submission Type