510(k) K883075
K883075 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "FASTIDIOUS INOCULUM BROTH". The FDA issued a decision of Substantially Equivalent on Aug 15, 1988. The device falls under product code JSD (Culture Media, Selective Broth), a Class I device regulated under 21 CFR 866.2360. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 15, 1988
- Date Received
- Jul 13, 1988
- 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