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510(k) K103037

IND URINARY TRACT INFECTION (UTI) TEST STRIPS by Ind Diagnostic, Inc. — Product Code NGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2012
Date Received
October 14, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
Device Class
Class I
Regulation Number
862.1510
Review Panel
TX
Submission Type

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  • K060810 — ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC (August 7, 2006)
  • K052694 — ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. (December 16, 2005)
  • K052662 — ONE STEP FSH MENOPAUSAL TEST (November 30, 2005)
  • K050741 — IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT (May 16, 2005)
  • K023638 — CASSETTE/URINE HCG (January 3, 2003)