510(k) K855207
K855207 is an FDA 510(k) premarket notification submitted by Difco Laboratories, Inc. for the device "IMIPENEM 10 MCG SENSITIVITY DISCS". The FDA issued a decision of Substantially Equivalent on Mar 6, 1986. The device falls under product code JTT (Susceptibility Test Powders, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Difco Laboratories, Inc. has 120 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 6, 1986
- Date Received
- Dec 30, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Susceptibility Test Powders, Antimicrobial
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
- 510(k)