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510(k) K970425

EZ SURE URINE DIPSTICK PREGNANCY HOME TEST by Excel Scientific, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1997
Date Received
February 4, 1997
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 Excel Scientific, Inc.

  • K971286 — EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST (May 8, 1997)
  • K970467 — EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT (March 18, 1997)
  • K970424 — EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST (March 6, 1997)
  • K963231 — EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST (December 4, 1996)
  • K962146 — EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT (October 7, 1996)
  • K962580 — EZ SURE ONESTEP EARLY PREGNANCY TEST (August 29, 1996)
  • K955707 — ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT (May 2, 1996)

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