510(k) K781875
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 1978
- Date Received
- November 3, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media And Components, Mycoplasma Detection
- Device Class
- Class I
- Regulation Number
- 864.2360
- Review Panel
- PA
- Submission Type