510(k) K962675

STA - LIATEST VWF TEST KIT by American Bioproducts Co. — Product Code GJT

K962675 is an FDA 510(k) premarket notification submitted by American Bioproducts Co. for the device "STA - LIATEST VWF TEST KIT". The FDA issued a decision of Substantially Equivalent on Oct 25, 1996. The device falls under product code GJT (Plasma, Coagulation Factor Deficient), a Class II device regulated under 21 CFR 864.7290. American Bioproducts Co. has 78 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 25, 1996
Date Received
Jul 9, 1996
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 K962675. Report a data issue: hello@regdatalab.com.