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510(k) K970467

EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT by Excel Scientific, Inc. — Product Code CEP

K970467 is an FDA 510(k) premarket notification submitted by Excel Scientific, Inc. for the device "EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT". The FDA issued a decision of Substantially Equivalent on March 18, 1997. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Excel Scientific, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1997
Date Received
February 7, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Luteinizing Hormone
Device Class
Class I
Regulation Number
862.1485
Review Panel
CH
Submission Type

Other clearances by Excel Scientific, Inc.

  • K971286 — EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST (May 8, 1997)
  • K970425 — EZ SURE URINE DIPSTICK PREGNANCY HOME TEST (March 6, 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)

Other clearances for product code CEP

  • K013582 — MAYBE?MOM MINI OVULATION MICROSCOPE (January 16, 2003)
  • K022829 — INSTANT-VIEW LH OVULATION PREDICTING TEST (November 5, 2002)
  • K021409 — AT HOME OVULATION TEST, MODEL 9032 (May 24, 2002)
  • K013874 — CLEARPLANE EASY OVULATION TEST (February 19, 2002)
  • K013323 — TCI-31 LIFELONG OVULATION TESTER (December 5, 2001)
  • K012252 — QUIK-CHECK OVULATION PREDICTOR (August 24, 2001)
  • K010244 — SURE CHECK OVULATION PREDICTOR (May 2, 2001)
  • K002867 — INVERNESS MEDICAL OVULATION PREDICTOR TEST (October 12, 2000)
  • K991466 — EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), O (May 25, 1999)
  • K991386 — EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATI (May 25, 1999)

FDA data resources