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FDA 510(k)

CANWEST OVU-BLUE

K-Number: K862055 · 1987-01-06

ApplicantCanwest Medictex, Inc.
Decision Date1987-01-06
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CANWEST OVU-BLUE is the device name listed in this FDA 510(k) record. The listed applicant is Canwest Medictex, Inc.. It received FDA 510(k) clearance on 1987-01-06 under 510(k) number K862055. 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 CANWEST OVU-BLUE?

CANWEST OVU-BLUE is a medical device that received FDA 510(k) clearance on 1987-01-06. The listed applicant is Canwest Medictex, Inc.. The 510(k) number is K862055.

When did CANWEST OVU-BLUE receive FDA 510(k) clearance?

CANWEST OVU-BLUE received FDA 510(k) clearance on 1987-01-06, under 510(k) number K862055.

Who is the listed applicant for CANWEST OVU-BLUE?

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

What is the FDA product code for CANWEST OVU-BLUE?

The FDA product code for CANWEST OVU-BLUE is CEP.

Related Clinical Trials

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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Other records listing Canwest Medictex, 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.

K854989CANWEST-PREGBLUE

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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