510(k) K960366
K960366 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 Apr 9, 1996. The device falls under product code LTT (Panels, Test, Susceptibility, Antimicrobial), 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
- Apr 9, 1996
- Date Received
- Jan 25, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Panels, Test, Susceptibility, Antimicrobial
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
- 510(k)