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FDA 510(k)

ALDOCTK-125

K-Number: K800775 · 1980-04-21

ApplicantSorin Biomedica, Fiat, USA, Inc.
Decision Date1980-04-21
Product CodeCJM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALDOCTK-125 is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1980-04-21 under 510(k) number K800775. 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 ALDOCTK-125?

ALDOCTK-125 is a medical device that received FDA 510(k) clearance on 1980-04-21. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K800775.

When did ALDOCTK-125 receive FDA 510(k) clearance?

ALDOCTK-125 received FDA 510(k) clearance on 1980-04-21, under 510(k) number K800775.

Who is the listed applicant for ALDOCTK-125?

The FDA 510(k) record lists Sorin Biomedica, Fiat, USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALDOCTK-125?

The FDA product code for ALDOCTK-125 is CJM.

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Other records listing Sorin Biomedica, Fiat, USA, Inc. as applicant

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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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