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FDA 510(k)

ALDOSTERONE RADIOIMMUNOASSAY TEST KIT

K-Number: K834428 · 1984-03-02

ApplicantSerono Laboratories, Inc.
Decision Date1984-03-02
Product CodeCJM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALDOSTERONE RADIOIMMUNOASSAY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Serono Laboratories, Inc.. It received FDA 510(k) clearance on 1984-03-02 under 510(k) number K834428. The device is classified under product code CJM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALDOSTERONE RADIOIMMUNOASSAY TEST KIT?

ALDOSTERONE RADIOIMMUNOASSAY TEST KIT is a medical device that received FDA 510(k) clearance on 1984-03-02. The listed applicant is Serono Laboratories, Inc.. The 510(k) number is K834428.

When did ALDOSTERONE RADIOIMMUNOASSAY TEST KIT receive FDA 510(k) clearance?

ALDOSTERONE RADIOIMMUNOASSAY TEST KIT received FDA 510(k) clearance on 1984-03-02, under 510(k) number K834428.

Who is the listed applicant for ALDOSTERONE RADIOIMMUNOASSAY TEST KIT?

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

What is the FDA product code for ALDOSTERONE RADIOIMMUNOASSAY TEST KIT?

The FDA product code for ALDOSTERONE RADIOIMMUNOASSAY TEST KIT is CJM.

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Other records listing Serono Laboratories, 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.

K810695ESTRIOL RADIOIMMUNOASSAY TEST KITK810625HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-K792043PAP-CHECK RIA KITK790679ESTRADIOL RIA KITK790440PROGESTERONEK782143RIA KIT, GLUCOSE

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Related Devices (Code: CJM)

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.

K130321LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERSDiasorinK050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYNichols Institute DiagnosticsK032188NICHOLS ADVANTAGE ALDOSTERONE ASSAYNichols Institute DiagnosticsK943397DSL ACTIVE ALDOSTERONE RIA (DSL 8600)Diagnostic Systems Laboratories, Inc.K921205DSL ACTIVE ALDOSTERONE (DSL 8600)Diagnostic Systems Laboratories, Inc.K862204RSL (125I) ALDOSTERONE KITRadioassay Systems Laboratories, 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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