510(k) K861774
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 1986
- Date Received
- May 7, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Identification, Enterobacteriaceae
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type