510(k) K781710

BUFFER, COLLAGEN REAGENT AND DILUENT by Diagnostica, Inc. — Product Code JBX

K781710 is an FDA 510(k) premarket notification submitted by Diagnostica, Inc. for the device "BUFFER, COLLAGEN REAGENT AND DILUENT". The FDA issued a decision of Substantially Equivalent on Oct 24, 1978. The device falls under product code JBX (Aggregrometer, Platelet), a Class II device regulated under 21 CFR 864.6675. Diagnostica, Inc. has 11 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 24, 1978
Date Received
Oct 5, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Aggregrometer, Platelet
Device Class
Class II
Regulation Number
864.6675
Review Panel
HE
Submission Type
510(k)

Source: FDA 510(k) database entry for K781710. Report a data issue: hello@regdatalab.com.