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FDA 510(k)

OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST

K-Number: K963693 · 1996-11-29

ApplicantPrinceton BioMeditech Corp.
Decision Date1996-11-29
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 1996-11-29 under 510(k) number K963693. 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 OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST?

OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST is a medical device that received FDA 510(k) clearance on 1996-11-29. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K963693.

When did OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST receive FDA 510(k) clearance?

OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST received FDA 510(k) clearance on 1996-11-29, under 510(k) number K963693.

Who is the listed applicant for OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST?

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

What is the FDA product code for OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST?

The FDA product code for OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST is CEP.

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Other records listing Princeton BioMeditech 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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