510(k) K111890

FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM by Taidoc Technology Corporation — Product Code NBW

K111890 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on Feb 6, 2012. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Taidoc Technology Corporation has 122 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 6, 2012
Date Received
Jul 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type
510(k)

Source: FDA 510(k) database entry for K111890. Report a data issue: hello@regdatalab.com.