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FDA 510(k)

OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031

K-Number: K990249 · 1999-03-22

ApplicantPhamatech
Decision Date1999-03-22
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech. It received FDA 510(k) clearance on 1999-03-22 under 510(k) number K990249. 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 OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031?

OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 is a medical device that received FDA 510(k) clearance on 1999-03-22. The listed applicant is Phamatech. The 510(k) number is K990249.

When did OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 receive FDA 510(k) clearance?

OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 received FDA 510(k) clearance on 1999-03-22, under 510(k) number K990249.

Who is the listed applicant for OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031?

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

What is the FDA product code for OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031?

The FDA product code for OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 is CEP.

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Other records listing Phamatech as applicant

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K041578QUICKSCREEN, MODELS 9177X AND 9178XK030447AT HOME DRUG CUP, MODEL 9150XK010833AT WORK DRUG TEST, MODEL 9177T AWTK010836AT WORK DRUG TEST, MODEL 9147T AWTK010655AT HOME DRUG TESTT, MODEL 9150 TK010653AT HOME DRUG TEST, MODEL 9068 T

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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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