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510(k) K993850

URINALYSIS REAGENT STRIPS (10 PARAMETERS) by International Newtech Development, Inc. — Product Code JMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2000
Date Received
November 12, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Device Class
Class I
Regulation Number
862.1510
Review Panel
CH
Submission Type

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  • K970176 — HCG CONTROLS (February 6, 1997)
  • K963133 — PS-UNIT CASSETTE/SERUM HCG (November 18, 1996)
  • K963132 — MINI STRIP/SERUM HCG (November 18, 1996)
  • K951705 — MINISTRIP HCG (October 3, 1995)

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