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510(k) K955707

ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT by Excel Scientific, Inc. — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1996
Date Received
December 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
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)
  • K970425 — EZ SURE URINE DIPSTICK PREGNANCY HOME 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)

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