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FDA 510(k)

QUIDEL QUEST OVULATION TEST

K-Number: K852146 · 1985-07-29

ApplicantQuidel Corp.
Decision Date1985-07-29
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUIDEL QUEST OVULATION TEST is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1985-07-29 under 510(k) number K852146. 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 QUIDEL QUEST OVULATION TEST?

QUIDEL QUEST OVULATION TEST is a medical device that received FDA 510(k) clearance on 1985-07-29. The listed applicant is Quidel Corp.. The 510(k) number is K852146.

When did QUIDEL QUEST OVULATION TEST receive FDA 510(k) clearance?

QUIDEL QUEST OVULATION TEST received FDA 510(k) clearance on 1985-07-29, under 510(k) number K852146.

Who is the listed applicant for QUIDEL QUEST OVULATION TEST?

The FDA 510(k) record lists Quidel Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUIDEL QUEST OVULATION TEST?

The FDA product code for QUIDEL QUEST OVULATION TEST is CEP.

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Other records listing Quidel Corp. as applicant

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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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