510(k) K863270
K863270 is an FDA 510(k) premarket notification submitted by Integrated Genetics for the device "GENE-TRAK CAMPYLOBACTER ASSAY". The FDA issued a decision of Substantially Equivalent on August 31, 1987. The device falls under product code LQO (Dna-Reagents, Campylobacter Spp.), a Class I device regulated under 21 CFR 866.3110.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1987
- Date Received
- August 25, 1986
- 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