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FDA 510(k)

GAMMADAB [125] FSH RADIOIMMUNAY KIT

K-Number: K821611 · 1982-06-24

ApplicantClinical Assays, Inc.
Decision Date1982-06-24
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMADAB [125] FSH RADIOIMMUNAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Assays, Inc.. It received FDA 510(k) clearance on 1982-06-24 under 510(k) number K821611. 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 GAMMADAB [125] FSH RADIOIMMUNAY KIT?

GAMMADAB [125] FSH RADIOIMMUNAY KIT is a medical device that received FDA 510(k) clearance on 1982-06-24. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K821611.

When did GAMMADAB [125] FSH RADIOIMMUNAY KIT receive FDA 510(k) clearance?

GAMMADAB [125] FSH RADIOIMMUNAY KIT received FDA 510(k) clearance on 1982-06-24, under 510(k) number K821611.

Who is the listed applicant for GAMMADAB [125] FSH RADIOIMMUNAY KIT?

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

What is the FDA product code for GAMMADAB [125] FSH RADIOIMMUNAY KIT?

The FDA product code for GAMMADAB [125] FSH RADIOIMMUNAY KIT is CGJ.

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Other records listing Clinical Assays, 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.

K832711VITAMIN B12 FOLATE CA-1515-125K832710VITAMIN B12 RADIOASSAY KIT CA-1534K832712FOLATE RADIOASSAY KIT CA-1562-125K823476GAMMADAB LH RADIO-KIT #CA-1508K823313IN VITRO GAMMACOAT B-HCG RADIO. TESTK821092GAMMADAB[125]EGE RADIOIMMUNOASSAY IT

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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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