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FDA 510(k)

AT HOME OVULATION TEST, MODEL 9032

K-Number: K021409 · 2002-05-24

ApplicantPhamatech, Inc.
Decision Date2002-05-24
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AT HOME OVULATION TEST, MODEL 9032 is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech, Inc.. It received FDA 510(k) clearance on 2002-05-24 under 510(k) number K021409. 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 AT HOME OVULATION TEST, MODEL 9032?

AT HOME OVULATION TEST, MODEL 9032 is a medical device that received FDA 510(k) clearance on 2002-05-24. The listed applicant is Phamatech, Inc.. The 510(k) number is K021409.

When did AT HOME OVULATION TEST, MODEL 9032 receive FDA 510(k) clearance?

AT HOME OVULATION TEST, MODEL 9032 received FDA 510(k) clearance on 2002-05-24, under 510(k) number K021409.

Who is the listed applicant for AT HOME OVULATION TEST, MODEL 9032?

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

What is the FDA product code for AT HOME OVULATION TEST, MODEL 9032?

The FDA product code for AT HOME OVULATION TEST, MODEL 9032 is CEP.

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Other records listing Phamatech, 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.

K181945QuickScreen Pro Multi Drug Screening Test, Model 9395ZK103295QUICKSCREEN COCAINE 150 SCREENING TESTK070098QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SCK070009AT HOME DRUG TEST MODELS, 9308T AND 9308XK043599MOMENTS MENOPAUSE CHECK, MODEL 9113K043051QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121

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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.K013874CLEARPLANE EASY OVULATION TESTUnipath , Ltd.K013323TCI-31 LIFELONG OVULATION TESTERTci New YorkK012252QUIK-CHECK OVULATION PREDICTORACON Laboratories, Inc.K010244SURE CHECK OVULATION PREDICTORChembio Diagnostic Systems, 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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