510(k) K032842
K032842 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "MICROGENICS CYCLOSPORINE CONTROL KIT". The FDA issued a decision of Substantially Equivalent on October 17, 2003. The device falls under product code LAS (Drug Specific Control Materials), a Class I device regulated under 21 CFR 862.3280. Microgenics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2003
- Date Received
- September 11, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drug Specific Control Materials
- Device Class
- Class I
- Regulation Number
- 862.3280
- Review Panel
- TX
- Submission Type