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510(k) K110889

IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) by Ind Diagnostics, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2011
Date Received
March 30, 2011
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

Other clearances by Ind Diagnostics, Inc.

  • K113506 — IND ONE STEP OCCULT BLOOD (FOB) TEST (December 19, 2012)

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