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FDA 510(k)

125I-ALDOSTERONE RIA DIAG. KIT

K-Number: K781504 · 1978-11-22

ApplicantAbbott Laboratories
Decision Date1978-11-22
Product CodeCJM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

125I-ALDOSTERONE RIA DIAG. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1978-11-22 under 510(k) number K781504. 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 125I-ALDOSTERONE RIA DIAG. KIT?

125I-ALDOSTERONE RIA DIAG. KIT is a medical device that received FDA 510(k) clearance on 1978-11-22. The listed applicant is Abbott Laboratories. The 510(k) number is K781504.

When did 125I-ALDOSTERONE RIA DIAG. KIT receive FDA 510(k) clearance?

125I-ALDOSTERONE RIA DIAG. KIT received FDA 510(k) clearance on 1978-11-22, under 510(k) number K781504.

Who is the listed applicant for 125I-ALDOSTERONE RIA DIAG. KIT?

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

What is the FDA product code for 125I-ALDOSTERONE RIA DIAG. KIT?

The FDA product code for 125I-ALDOSTERONE RIA DIAG. KIT is CJM.

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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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