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FDA 510(k)

MODEL 5100 ELECTROCHEMICAL DETECTOR

K-Number: K801439 · 1980-07-21

ApplicantEnvironmental Sciences Assoc., Inc.
Decision Date1980-07-21
Product CodeLEQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODEL 5100 ELECTROCHEMICAL DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Environmental Sciences Assoc., Inc.. It received FDA 510(k) clearance on 1980-07-21 under 510(k) number K801439. The device is classified under product code LEQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 5100 ELECTROCHEMICAL DETECTOR?

MODEL 5100 ELECTROCHEMICAL DETECTOR is a medical device that received FDA 510(k) clearance on 1980-07-21. The listed applicant is Environmental Sciences Assoc., Inc.. The 510(k) number is K801439.

When did MODEL 5100 ELECTROCHEMICAL DETECTOR receive FDA 510(k) clearance?

MODEL 5100 ELECTROCHEMICAL DETECTOR received FDA 510(k) clearance on 1980-07-21, under 510(k) number K801439.

Who is the listed applicant for MODEL 5100 ELECTROCHEMICAL DETECTOR?

The FDA 510(k) record lists Environmental Sciences Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 5100 ELECTROCHEMICAL DETECTOR?

The FDA product code for MODEL 5100 ELECTROCHEMICAL DETECTOR is LEQ.

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 Environmental Sciences Assoc., 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.

K781009ANALYZER, SERUM IRON & TOTAL IRON BINDIN

Related Devices (Code: LEQ)

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.

K962574WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)Waters CorporationK903231COULOCHEM IIEsa, Inc.K864729NEUROCHEMICAL ANALYZEREsa, 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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