510(k) K864241
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1987
- Date Received
- October 28, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Single Biochemical Test
- Device Class
- Class I
- Regulation Number
- 866.2320
- Review Panel
- MI
- Submission Type