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FDA 510(k)

EARLYDETECT MENOPAUSE TEST FOR FSH

K-Number: K030058 · 2003-07-30

ApplicantEarly Detect, Inc.
Decision Date2003-07-30
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EARLYDETECT MENOPAUSE TEST FOR FSH is the device name listed in this FDA 510(k) record. The listed applicant is Early Detect, Inc.. It received FDA 510(k) clearance on 2003-07-30 under 510(k) number K030058. 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 EARLYDETECT MENOPAUSE TEST FOR FSH?

EARLYDETECT MENOPAUSE TEST FOR FSH is a medical device that received FDA 510(k) clearance on 2003-07-30. The listed applicant is Early Detect, Inc.. The 510(k) number is K030058.

When did EARLYDETECT MENOPAUSE TEST FOR FSH receive FDA 510(k) clearance?

EARLYDETECT MENOPAUSE TEST FOR FSH received FDA 510(k) clearance on 2003-07-30, under 510(k) number K030058.

Who is the listed applicant for EARLYDETECT MENOPAUSE TEST FOR FSH?

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

What is the FDA product code for EARLYDETECT MENOPAUSE TEST FOR FSH?

The FDA product code for EARLYDETECT MENOPAUSE TEST FOR FSH is CGJ.

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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.K043599MOMENTS MENOPAUSE CHECK, MODEL 9113Phamatech, Inc.K041165FSH MENOPAUSE PREDICTOR TESTACON Laboratories, Inc.K040575PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112Phamatech, 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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