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FDA 510(k)

MODIFIED OVUGEN

K-Number: K902208 · 1990-07-17

ApplicantBiogenex Laboratories
Decision Date1990-07-17
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED OVUGEN is the device name listed in this FDA 510(k) record. The listed applicant is Biogenex Laboratories. It received FDA 510(k) clearance on 1990-07-17 under 510(k) number K902208. 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 MODIFIED OVUGEN?

MODIFIED OVUGEN is a medical device that received FDA 510(k) clearance on 1990-07-17. The listed applicant is Biogenex Laboratories. The 510(k) number is K902208.

When did MODIFIED OVUGEN receive FDA 510(k) clearance?

MODIFIED OVUGEN received FDA 510(k) clearance on 1990-07-17, under 510(k) number K902208.

Who is the listed applicant for MODIFIED OVUGEN?

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

What is the FDA product code for MODIFIED OVUGEN?

The FDA product code for MODIFIED OVUGEN is CEP.

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Other records listing Biogenex Laboratories 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.

K012960BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTORK013148BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)K925189PREGNAGEN 1-STEP PREGNANCY TESTK884880PREGNAGEN(TM)K882002PREGNAGEN(TM)K873534OVUGEN SURETEST

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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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