510(k) K960235
K960235 is an FDA 510(k) premarket notification submitted by Accumed Intl., Inc. for the device "SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES". The FDA issued a decision of Substantially Equivalent on Mar 27, 1996. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Accumed Intl., Inc. has 11 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 27, 1996
- Date Received
- Jan 17, 1996
- 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
- 510(k)