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FDA 510(k)

FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT

K-Number: K862813 · 1986-09-16

ApplicantSerono Diagnostics, Inc.
Decision Date1986-09-16
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Serono Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-09-16 under 510(k) number K862813. 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 MAIACLONE IMMUNORADIOMETRIC ASSAY KIT?

FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT is a medical device that received FDA 510(k) clearance on 1986-09-16. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K862813.

When did FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT receive FDA 510(k) clearance?

FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT received FDA 510(k) clearance on 1986-09-16, under 510(k) number K862813.

Who is the listed applicant for FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT?

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

What is the FDA product code for FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT?

The FDA product code for FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT is CGJ.

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Other records listing Serono Diagnostics, 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.

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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.K030058EARLYDETECT MENOPAUSE TEST FOR FSHEarly Detect, Inc.K002450GENUA MENOPAUSE MONITOR TEST KITGenua 1944, 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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