510(k) K970009
K970009 is an FDA 510(k) premarket notification submitted by Microbiologics, Inc. for the device "LYFO(TM) DIFFERENTIAL DISK-BACITRACIN". The FDA issued a decision of Substantially Equivalent on February 6, 1997. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660. Microbiologics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 1997
- Date Received
- January 2, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Discs, Strips And Reagents, Microorganism Differentiation
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type