510(k) K900377
K900377 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN". The FDA issued a decision of Substantially Equivalent on Mar 6, 1990. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), 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
- Mar 6, 1990
- Date Received
- Jan 26, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Multipurpose For In Vitro Coagulation Studies
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type
- 510(k)