510(k) K962745
K962745 is an FDA 510(k) premarket notification submitted by Prepared Media Laboratory, Inc. for the device "ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)". The FDA issued a decision of Substantially Equivalent on October 2, 1996. The device falls under product code JSN (Culture Media, Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Prepared Media Laboratory, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1996
- Date Received
- July 15, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Propagating Transport
- Device Class
- Class I
- Regulation Number
- 866.2390
- Review Panel
- MI
- Submission Type