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510(k) K951705

MINISTRIP HCG by International Newtech Development, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1995
Date Received
April 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by International Newtech Development, Inc.

  • K993850 — URINALYSIS REAGENT STRIPS (10 PARAMETERS) (January 3, 2000)
  • K974060 — MINISTRIP/ SERUM AND URINE COMBO HCG TEST (April 9, 1998)
  • K974059 — ONE STEP MIDSTREAM HCG PREGNANCY TEST (April 9, 1998)
  • K974009 — PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG (March 13, 1998)
  • K970176 — HCG CONTROLS (February 6, 1997)
  • K963132 — MINI STRIP/SERUM HCG (November 18, 1996)
  • K963133 — PS-UNIT CASSETTE/SERUM HCG (November 18, 1996)

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  • K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (July 17, 2012)