510(k) K882795
K882795 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DADE(R) CK-MB IMMUNOASSAY CONTROL". The FDA issued a decision of Substantially Equivalent on Aug 29, 1988. The device falls under product code JJT (Enzyme Controls (Assayed And Unassayed)), 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
- Aug 29, 1988
- Date Received
- Jul 6, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Enzyme Controls (Assayed And Unassayed)
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type
- 510(k) Exempt