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FDA 510(k)

ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER

K-Number: K853531 · 1985-09-04

ApplicantAmerican Dade
Decision Date1985-09-04
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1985-09-04 under 510(k) number K853531. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER?

ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER is a medical device that received FDA 510(k) clearance on 1985-09-04. The listed applicant is American Dade. The 510(k) number is K853531.

When did ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER receive FDA 510(k) clearance?

ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER received FDA 510(k) clearance on 1985-09-04, under 510(k) number K853531.

Who is the listed applicant for ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER?

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

What is the FDA product code for ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER?

The FDA product code for ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER is CEM.

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Other records listing American Dade as applicant

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Related Devices (Code: CEM)

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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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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