510(k) K873263
K873263 is an FDA 510(k) premarket notification submitted by Central Media for the device "MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA". The FDA issued a decision of Substantially Equivalent on Oct 28, 1987. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. Central Media has 13 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 28, 1987
- Date Received
- Aug 11, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Culture Media, Non-Selective And Differential
- Device Class
- Class I
- Regulation Number
- 866.2320
- Review Panel
- MI
- Submission Type
- 510(k) Exempt