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510(k) K971286

EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST by Excel Scientific, Inc. — Product Code LCX

K971286 is an FDA 510(k) premarket notification submitted by Excel Scientific, Inc. for the device "EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST". The FDA issued a decision of Substantially Equivalent on May 8, 1997. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Excel Scientific, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1997
Date Received
April 7, 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.

  • 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)
  • K955707 — ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT (May 2, 1996)

Other clearances for product code LCX

  • K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital P (September 9, 2025)
  • K251053 — Shinetell PlusTM Digital Early Pregnancy Test (July 15, 2025)
  • K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (February 13, 2025)
  • K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synth (January 31, 2025)
  • K243573 — FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Casse (January 15, 2025)
  • K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (December 20, 2024)
  • K240242 — HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test (October 11, 2024)
  • K241978 — Shinetell Digital Pregnancy Test (August 13, 2024)
  • K240643 — MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnanc (June 21, 2024)
  • K232715 — Distinct® Digital Pregnancy Test (May 31, 2024)

FDA data resources