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FDA 510(k)

RSL (125I) ALDOSTERONE KIT

K-Number: K862204 · 1986-09-25

ApplicantRadioassay Systems Laboratories, Inc.
Decision Date1986-09-25
Product CodeCJM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RSL (125I) ALDOSTERONE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Radioassay Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1986-09-25 under 510(k) number K862204. 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 RSL (125I) ALDOSTERONE KIT?

RSL (125I) ALDOSTERONE KIT is a medical device that received FDA 510(k) clearance on 1986-09-25. The listed applicant is Radioassay Systems Laboratories, Inc.. The 510(k) number is K862204.

When did RSL (125I) ALDOSTERONE KIT receive FDA 510(k) clearance?

RSL (125I) ALDOSTERONE KIT received FDA 510(k) clearance on 1986-09-25, under 510(k) number K862204.

Who is the listed applicant for RSL (125I) ALDOSTERONE KIT?

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

What is the FDA product code for RSL (125I) ALDOSTERONE KIT?

The FDA product code for RSL (125I) ALDOSTERONE KIT is CJM.

Related Clinical Trials

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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Other records listing Radioassay Systems 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.

K842960ANDROSTENEDIONE BY RIAK840886HYDROXYPROGESTERONE BY RIA 17AK831855HATCH KITK802195DEHYDROEPIANDROSTERONE SULFATE KIT RIAK800126RSL (125 L) PROGESTERONE KITK791999(125I) TESTOSTERONE KIT

View all 15 devices →

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.K834428ALDOSTERONE RADIOIMMUNOASSAY TEST KITSerono 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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