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FDA 510(k)

125-I FSH RADIOIMMUNOASSAY KIT

K-Number: K823379 · 1982-12-22

ApplicantClinetics Corp.
Decision Date1982-12-22
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

125-I FSH RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Clinetics Corp.. It received FDA 510(k) clearance on 1982-12-22 under 510(k) number K823379. 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 125-I FSH RADIOIMMUNOASSAY KIT?

125-I FSH RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1982-12-22. The listed applicant is Clinetics Corp.. The 510(k) number is K823379.

When did 125-I FSH RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

125-I FSH RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1982-12-22, under 510(k) number K823379.

Who is the listed applicant for 125-I FSH RADIOIMMUNOASSAY KIT?

The FDA 510(k) record lists Clinetics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 125-I FSH RADIOIMMUNOASSAY KIT?

The FDA product code for 125-I FSH RADIOIMMUNOASSAY KIT is CGJ.

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Other records listing Clinetics Corp. 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.

K862180MODIFIED COTROPIN RADIOIMMUNOASSAY KITK844066COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSHK841580TSH RECEPTOR ANTIBODY KIT 125I TSHK833934ADRENOCORTICOTROPIC HORMONE TESTK830357RADIOIMMUNOASSAY IMMUNOGLOBULINS D.EK823380125-I LH RADIOIMMUNOASSAY KIT

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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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