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FDA 510(k)

IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I

K-Number: K843930 · 1984-10-30

ApplicantEuro-Diagnostics BV
Decision Date1984-10-30
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I is the device name listed in this FDA 510(k) record. The listed applicant is Euro-Diagnostics BV. It received FDA 510(k) clearance on 1984-10-30 under 510(k) number K843930. 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 IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I?

IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I is a medical device that received FDA 510(k) clearance on 1984-10-30. The listed applicant is Euro-Diagnostics BV. The 510(k) number is K843930.

When did IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I receive FDA 510(k) clearance?

IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I received FDA 510(k) clearance on 1984-10-30, under 510(k) number K843930.

Who is the listed applicant for IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I?

The FDA 510(k) record lists Euro-Diagnostics BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I?

The FDA product code for IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I is CGJ.

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Other records listing Euro-Diagnostics BV 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.

K851332BLHI LUTEINIZING HORMONEK851148TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONEK850053BACI 6 -ADRENOCORTICOTROOP HORMONEK842478PROLACTIN IRMA

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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