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510(k) K063390

URINE CHEMISTRY ANALYZER UR-50 by Ind Diagnostic, Inc. — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2007
Date Received
November 9, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
Submission Type

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  • 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)

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