510(k) K896846
K896846 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "MADIN-DARBY CANINE KIDNEY CULTURE CELLS". The FDA issued a decision of Substantially Equivalent on Feb 1, 1990. The device falls under product code KIR (Cells, Animal And Human, Cultured), a Class I device regulated under 21 CFR 864.2280. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 1, 1990
- Date Received
- Dec 5, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Cells, Animal And Human, Cultured
- Device Class
- Class I
- Regulation Number
- 864.2280
- Review Panel
- PA
- Submission Type
- 510(k) Exempt