510(k) K032246
K032246 is an FDA 510(k) premarket notification submitted by Starplex Scientific, Inc. for the device "MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on August 13, 2003. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Starplex Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2003
- Date Received
- July 22, 2003
- Clearance Type
- Special
- 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