510(k) K971211
K971211 is an FDA 510(k) premarket notification submitted by Difco Laboratories, Inc. for the device "DISPENS-O-DISC SPARFLOXACIN". The FDA issued a decision of Substantially Equivalent on April 14, 1997. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Difco Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 1997
- Date Received
- March 27, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Susceptibility Test Discs, Antimicrobial
- Device Class
- Class II
- Regulation Number
- 866.1620
- Review Panel
- MI
- Submission Type