510(k) K880874

IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN by Baxter Healthcare Corp — Product Code GJT

K880874 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN". The FDA issued a decision of Substantially Equivalent on Mar 17, 1988. The device falls under product code GJT (Plasma, Coagulation Factor Deficient), 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
Mar 17, 1988
Date Received
Mar 1, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Plasma, Coagulation Factor Deficient
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type
510(k)

Source: FDA 510(k) database entry for K880874. Report a data issue: hello@regdatalab.com.