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FDA 510(k)

EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT

K-Number: K970467 · 1997-03-18

ApplicantExcel Scientific, Inc.
Decision Date1997-03-18
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Excel Scientific, Inc.. It received FDA 510(k) clearance on 1997-03-18 under 510(k) number K970467. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT?

EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT is a medical device that received FDA 510(k) clearance on 1997-03-18. The listed applicant is Excel Scientific, Inc.. The 510(k) number is K970467.

When did EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT receive FDA 510(k) clearance?

EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT received FDA 510(k) clearance on 1997-03-18, under 510(k) number K970467.

Who is the listed applicant for EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT?

The FDA 510(k) record lists Excel Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT?

The FDA product code for EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT is CEP.

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Other records listing Excel Scientific, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971286EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TESTK970425EZ SURE URINE DIPSTICK PREGNANCY HOME TESTK970424EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TESTK963231EXCEL ONESTEP URINE HCG MODULE PREGNANCY TESTK962146EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KITK962580EZ SURE ONESTEP EARLY PREGNANCY TEST

View all 8 devices →

Related Devices (Code: CEP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013582MAYBE?MOM MINI OVULATION MICROSCOPEMaybe?MomK022829INSTANT-VIEW LH OVULATION PREDICTING TESTAlfa Scientific Designs, Inc.K021409AT HOME OVULATION TEST, MODEL 9032Phamatech, Inc.K013874CLEARPLANE EASY OVULATION TESTUnipath , Ltd.K013323TCI-31 LIFELONG OVULATION TESTERTci New YorkK012252QUIK-CHECK OVULATION PREDICTORACON Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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