510(k) K911885
K911885 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DADE(R) PROTEIN C ABNORMAL CONTRAL". The FDA issued a decision of Substantially Equivalent on Jun 11, 1991. The device falls under product code GGC (Control, Plasma, Abnormal), 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
- Jun 11, 1991
- Date Received
- Apr 29, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Control, Plasma, Abnormal
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type
- 510(k) Exempt