510(k) K024082

HEMOSIL FACTOR VII DEFICIENT PLASMA by Instrumentation Laboratory CO — Product Code GJT

K024082 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL FACTOR VII DEFICIENT PLASMA". The FDA issued a decision of Substantially Equivalent on Feb 12, 2003. The device falls under product code GJT (Plasma, Coagulation Factor Deficient), a Class II device regulated under 21 CFR 864.7290. Instrumentation Laboratory CO has 326 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 12, 2003
Date Received
Dec 11, 2002
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 K024082. Report a data issue: hello@regdatalab.com.