510(k) K023202
K023202 is an FDA 510(k) premarket notification submitted by Dade Microscan, Inc. for the device "MICROSCAN SYNERGIES PLUS". The FDA issued a decision of Substantially Equivalent on October 23, 2002. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Dade Microscan, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 2002
- Date Received
- September 25, 2002
- Clearance Type
- Special
- 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