510(k) K822131
K822131 is an FDA 510(k) premarket notification submitted by Granite Diagnostics, Inc. for the device "DERMATOPHYTE TEST MEDIUM". The FDA issued a decision of Substantially Equivalent on Aug 3, 1982. The device falls under product code JSD (Culture Media, Selective Broth), a Class I device regulated under 21 CFR 866.2360. Granite Diagnostics, Inc. has 46 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 1982
- Date Received
- Jul 19, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Culture Media, Selective Broth
- Device Class
- Class I
- Regulation Number
- 866.2360
- Review Panel
- MI
- Submission Type
- 510(k) Exempt