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FDA 510(k)

RIGHT-DAY OVULATION HOME TEST

K-Number: K861354 · 1986-09-16

ApplicantLeeco Diagnostics, Inc.
Decision Date1986-09-16
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIGHT-DAY OVULATION HOME TEST is the device name listed in this FDA 510(k) record. The listed applicant is Leeco Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-09-16 under 510(k) number K861354. 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 RIGHT-DAY OVULATION HOME TEST?

RIGHT-DAY OVULATION HOME TEST is a medical device that received FDA 510(k) clearance on 1986-09-16. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K861354.

When did RIGHT-DAY OVULATION HOME TEST receive FDA 510(k) clearance?

RIGHT-DAY OVULATION HOME TEST received FDA 510(k) clearance on 1986-09-16, under 510(k) number K861354.

Who is the listed applicant for RIGHT-DAY OVULATION HOME TEST?

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

What is the FDA product code for RIGHT-DAY OVULATION HOME TEST?

The FDA product code for RIGHT-DAY OVULATION HOME TEST is CEP.

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Other records listing Leeco Diagnostics, 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.

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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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