510(k) K000398
K000398 is an FDA 510(k) premarket notification submitted by Shield Diagnostics, Ltd. for the device "SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200". The FDA issued a decision of Substantially Equivalent on April 17, 2000. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Shield Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2000
- Date Received
- February 7, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Qualitative And Quantitative Factor Deficiency
- Device Class
- Class II
- Regulation Number
- 864.7290
- Review Panel
- HE
- Submission Type