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FDA 510(k)

IMMUCHEM LH-MW ELISA

K-Number: K922944 · 1993-02-02

ApplicantIcn Biomedicals, Inc.
Decision Date1993-02-02
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMUCHEM LH-MW ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Icn Biomedicals, Inc.. It received FDA 510(k) clearance on 1993-02-02 under 510(k) number K922944. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUCHEM LH-MW ELISA?

IMMUCHEM LH-MW ELISA is a medical device that received FDA 510(k) clearance on 1993-02-02. The listed applicant is Icn Biomedicals, Inc.. The 510(k) number is K922944.

When did IMMUCHEM LH-MW ELISA receive FDA 510(k) clearance?

IMMUCHEM LH-MW ELISA received FDA 510(k) clearance on 1993-02-02, under 510(k) number K922944.

Who is the listed applicant for IMMUCHEM LH-MW ELISA?

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

What is the FDA product code for IMMUCHEM LH-MW ELISA?

The FDA product code for IMMUCHEM LH-MW ELISA is CEP.

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Related Devices (Code: CEP)

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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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