510(k) K103487

FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST by Taidoc Technology Corporation — Product Code LCX

K103487 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST". The FDA issued a decision of Substantially Equivalent on Oct 4, 2011. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Taidoc Technology Corporation has 122 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 4, 2011
Date Received
Nov 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type
510(k)

Source: FDA 510(k) database entry for K103487. Report a data issue: hello@regdatalab.com.