510(k) K920001
K920001 is an FDA 510(k) premarket notification submitted by Biomerieux Vitek, Inc. for the device "HEMOLAB SILIMAT REAGENT". The FDA issued a decision of Substantially Equivalent on September 25, 1992. The device falls under product code GFI (Osteotome, Manual), a Class I device regulated under 21 CFR 878.4800. Biomerieux Vitek, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 1992
- Date Received
- January 2, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Osteotome, Manual
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type