510(k) K841222
K841222 is an FDA 510(k) premarket notification submitted by Anaerobe Systems for the device "BACTEROIDES BILE ESCULIN GAR". The FDA issued a decision of Substantially Equivalent on Apr 4, 1984. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Anaerobe Systems has 51 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 4, 1984
- Date Received
- Mar 22, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Culture Media, Selective And Differential
- Device Class
- Class I
- Regulation Number
- 866.2360
- Review Panel
- MI
- Submission Type
- 510(k) Exempt