510(k) K884551
K884551 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DADE FACTOR IX CHROMOGENIC ASSAY". The FDA issued a decision of Substantially Equivalent on Dec 30, 1988. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 30, 1988
- Date Received
- Oct 31, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Test, Qualitative And Quantitative Factor Deficiency
- Device Class
- Class II
- Regulation Number
- 864.7290
- Review Panel
- HE
- Submission Type
- 510(k)