510(k) K990206
K990206 is an FDA 510(k) premarket notification submitted by Serim Research Corp. for the device "SERIM BLOOD LEAK TEST STRIP". The FDA issued a decision of Substantially Equivalent on April 21, 1999. The device falls under product code FJD (Detector, Leak, Blood), a Class II device regulated under 21 CFR 876.5820. Serim Research Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1999
- Date Received
- January 21, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector, Leak, Blood
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type