510(k) K945997
K945997 is an FDA 510(k) premarket notification submitted by Micro-Media Systems, Inc. for the device "MODIFIED FOX EXTRA GRAM POSITIVE". The FDA issued a decision of Substantially Equivalent on February 16, 1995. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Micro-Media Systems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 1995
- Date Received
- October 7, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Manual Antimicrobial Susceptibility Test Systems
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type