510(k) K904968
K904968 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "QCLYTE PROTEIN BASED ISE CONTROL". The FDA issued a decision of Substantially Equivalent on Dec 6, 1990. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 6, 1990
- Date Received
- Nov 5, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Multi-Analyte Controls, All Kinds (Assayed)
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type
- 510(k) Exempt