510(k) K923892
K923892 is an FDA 510(k) premarket notification submitted by Smith River Biologicals for the device "SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA". The FDA issued a decision of Substantially Equivalent on June 21, 1993. The device falls under product code JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar), a Class II device regulated under 21 CFR 866.1700. Smith River Biologicals has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1993
- Date Received
- August 4, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- Device Class
- Class II
- Regulation Number
- 866.1700
- Review Panel
- MI
- Submission Type