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FDA 510(k)

COULOCHEM II

K-Number: K903231 · 1990-09-27

ApplicantEsa, Inc.
Decision Date1990-09-27
Product CodeLEQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULOCHEM II is the device name listed in this FDA 510(k) record. The listed applicant is Esa, Inc.. It received FDA 510(k) clearance on 1990-09-27 under 510(k) number K903231. 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 COULOCHEM II?

COULOCHEM II is a medical device that received FDA 510(k) clearance on 1990-09-27. The listed applicant is Esa, Inc.. The 510(k) number is K903231.

When did COULOCHEM II receive FDA 510(k) clearance?

COULOCHEM II received FDA 510(k) clearance on 1990-09-27, under 510(k) number K903231.

Who is the listed applicant for COULOCHEM II?

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

What is the FDA product code for COULOCHEM II?

The FDA product code for COULOCHEM II 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 Esa, 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.

K032199ESA PLASMA FREE METANEPHRINE ANALYSIS KITK971640LEADCARE BLOOD LEAD TESTING SYSTEMK963938MODEL 5500 CEASK934977MODEL 5500 CEASK931148MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEMK864729NEUROCHEMICAL ANALYZER

View all 7 devices →

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 CorporationK864729NEUROCHEMICAL ANALYZEREsa, Inc.K801439MODEL 5100 ELECTROCHEMICAL DETECTOREnvironmental Sciences Assoc., 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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