510(k) K042687
K042687 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "ENZYGNOST F+2 (MONOCLONAL) TEST KIT". The FDA issued a decision of Substantially Equivalent on December 10, 2004. The device falls under product code MIF (Prothrombin Fragment 1.2), a Class II device regulated under 21 CFR 864.7320. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 2004
- Date Received
- September 29, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prothrombin Fragment 1.2
- Device Class
- Class II
- Regulation Number
- 864.7320
- Review Panel
- HE
- Submission Type