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FDA 510(k)

DISCRETE CLINICAL ANALYZER

K-Number: K834521 · 1984-02-27

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1984-02-27
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DISCRETE CLINICAL ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1984-02-27 under 510(k) number K834521. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISCRETE CLINICAL ANALYZER?

DISCRETE CLINICAL ANALYZER is a medical device that received FDA 510(k) clearance on 1984-02-27. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K834521.

When did DISCRETE CLINICAL ANALYZER receive FDA 510(k) clearance?

DISCRETE CLINICAL ANALYZER received FDA 510(k) clearance on 1984-02-27, under 510(k) number K834521.

Who is the listed applicant for DISCRETE CLINICAL ANALYZER?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISCRETE CLINICAL ANALYZER?

The FDA product code for DISCRETE CLINICAL ANALYZER is JJE.

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Other records listing E.I. Dupont DE Nemours & Co., Inc. as applicant

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Related Devices (Code: JJE)

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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