510(k) K884901
K884901 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO". The FDA issued a decision of Substantially Equivalent on Feb 2, 1989. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 2, 1989
- Date Received
- Nov 23, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Plasma, Coagulation Control
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type
- 510(k) Exempt