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FDA 510(k)

ONE STEP FSH MENOPAUSAL TEST

K-Number: K052662 · 2005-11-30

ApplicantInd Diagnostic, Inc.
Decision Date2005-11-30
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONE STEP FSH MENOPAUSAL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ind Diagnostic, Inc.. It received FDA 510(k) clearance on 2005-11-30 under 510(k) number K052662. 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 ONE STEP FSH MENOPAUSAL TEST?

ONE STEP FSH MENOPAUSAL TEST is a medical device that received FDA 510(k) clearance on 2005-11-30. The listed applicant is Ind Diagnostic, Inc.. The 510(k) number is K052662.

When did ONE STEP FSH MENOPAUSAL TEST receive FDA 510(k) clearance?

ONE STEP FSH MENOPAUSAL TEST received FDA 510(k) clearance on 2005-11-30, under 510(k) number K052662.

Who is the listed applicant for ONE STEP FSH MENOPAUSAL TEST?

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

What is the FDA product code for ONE STEP FSH MENOPAUSAL TEST?

The FDA product code for ONE STEP FSH MENOPAUSAL TEST is CGJ.

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Other records listing Ind Diagnostic, 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.

K103037IND URINARY TRACT INFECTION (UTI) TEST STRIPSK100031IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10K063390URINE CHEMISTRY ANALYZER UR-50K060810ONE STEP DRUG TEST - AMP/MET/MOR/THC/COCK052694ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.K050741IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT

View all 8 devices →

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.

K043599MOMENTS MENOPAUSE CHECK, MODEL 9113Phamatech, 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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