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FDA 510(k)

BIOCLONES ELEGANCE FSH ELISA KIT

K-Number: K904405 · 1990-10-26

ApplicantBioclone Australia Pty , Ltd.
Decision Date1990-10-26
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOCLONES ELEGANCE FSH ELISA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bioclone Australia Pty , Ltd.. It received FDA 510(k) clearance on 1990-10-26 under 510(k) number K904405. 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 BIOCLONES ELEGANCE FSH ELISA KIT?

BIOCLONES ELEGANCE FSH ELISA KIT is a medical device that received FDA 510(k) clearance on 1990-10-26. The listed applicant is Bioclone Australia Pty , Ltd.. The 510(k) number is K904405.

When did BIOCLONES ELEGANCE FSH ELISA KIT receive FDA 510(k) clearance?

BIOCLONES ELEGANCE FSH ELISA KIT received FDA 510(k) clearance on 1990-10-26, under 510(k) number K904405.

Who is the listed applicant for BIOCLONES ELEGANCE FSH ELISA KIT?

The FDA 510(k) record lists Bioclone Australia Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOCLONES ELEGANCE FSH ELISA KIT?

The FDA product code for BIOCLONES ELEGANCE FSH ELISA KIT is CGJ.

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Other records listing Bioclone Australia Pty , Ltd. 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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