510(k) K863164
K863164 is an FDA 510(k) premarket notification submitted by Precision Dynamics Corp. for the device "AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA". The FDA issued a decision of Substantially Equivalent on August 27, 1986. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Precision Dynamics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 1986
- Date Received
- August 18, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Non-Propagating Transport
- Device Class
- Class I
- Regulation Number
- 866.2390
- Review Panel
- MI
- Submission Type