510(k) K922768
K922768 is an FDA 510(k) premarket notification submitted by Biomerieux Vitek, Inc. for the device "RAPID NFT, MODIFICATION". The FDA issued a decision of Substantially Equivalent on October 14, 1992. The device falls under product code JSW (Kit, Identification, Glucose Nonfermenter), a Class I device regulated under 21 CFR 866.2660. Biomerieux Vitek, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 1992
- Date Received
- June 8, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Identification, Glucose Nonfermenter
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type