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FDA 510(k)

FSH MENOPAUSE PREDICTOR TEST

K-Number: K041165 · 2004-06-17

ApplicantACON Laboratories, Inc.
Decision Date2004-06-17
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FSH MENOPAUSE PREDICTOR TEST is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2004-06-17 under 510(k) number K041165. 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 FSH MENOPAUSE PREDICTOR TEST?

FSH MENOPAUSE PREDICTOR TEST is a medical device that received FDA 510(k) clearance on 2004-06-17. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K041165.

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

FSH MENOPAUSE PREDICTOR TEST received FDA 510(k) clearance on 2004-06-17, under 510(k) number K041165.

Who is the listed applicant for FSH MENOPAUSE PREDICTOR TEST?

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

What is the FDA product code for FSH MENOPAUSE PREDICTOR TEST?

The FDA product code for FSH MENOPAUSE PREDICTOR TEST is CGJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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