510(k) K890339
K890339 is an FDA 510(k) premarket notification submitted by Difco Laboratories, Inc. for the device "DIFCO DIRECTOR INOCULATION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 7, 1989. The device falls under product code LIE (Reagent/Device, Inoculum Calibration), a Class II device regulated under 21 CFR 866.1640. Difco Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1989
- Date Received
- January 23, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent/Device, Inoculum Calibration
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type