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FDA 510(k)

MOMENTS MENOPAUSE CHECK, MODEL 9113

K-Number: K043599 · 2005-02-25

ApplicantPhamatech, Inc.
Decision Date2005-02-25
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MOMENTS MENOPAUSE CHECK, MODEL 9113 is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech, Inc.. It received FDA 510(k) clearance on 2005-02-25 under 510(k) number K043599. The device is classified under product code CGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOMENTS MENOPAUSE CHECK, MODEL 9113?

MOMENTS MENOPAUSE CHECK, MODEL 9113 is a medical device that received FDA 510(k) clearance on 2005-02-25. The listed applicant is Phamatech, Inc.. The 510(k) number is K043599.

When did MOMENTS MENOPAUSE CHECK, MODEL 9113 receive FDA 510(k) clearance?

MOMENTS MENOPAUSE CHECK, MODEL 9113 received FDA 510(k) clearance on 2005-02-25, under 510(k) number K043599.

Who is the listed applicant for MOMENTS MENOPAUSE CHECK, MODEL 9113?

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 MOMENTS MENOPAUSE CHECK, MODEL 9113?

The FDA product code for MOMENTS MENOPAUSE CHECK, MODEL 9113 is CGJ.

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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 9308XK043051QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121K043167PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X

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Related Devices (Code: CGJ)

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.

K052662ONE STEP FSH MENOPAUSAL TESTInd Diagnostic, Inc.K041165FSH MENOPAUSE PREDICTOR TESTACON Laboratories, Inc.K040575PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112Phamatech, Inc.K030058EARLYDETECT MENOPAUSE TEST FOR FSHEarly Detect, Inc.K002450GENUA MENOPAUSE MONITOR TEST KITGenua 1944, Inc.K972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)Monobind

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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