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FDA 510(k)

IMMULISA SCI-70 ANTIBODY ELISA

K-Number: K113143 · 2011-12-02

ApplicantImmco Diagnostics, Inc.
Decision Date2011-12-02
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULISA SCI-70 ANTIBODY ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 2011-12-02 under 510(k) number K113143. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULISA SCI-70 ANTIBODY ELISA?

IMMULISA SCI-70 ANTIBODY ELISA is a medical device that received FDA 510(k) clearance on 2011-12-02. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K113143.

When did IMMULISA SCI-70 ANTIBODY ELISA receive FDA 510(k) clearance?

IMMULISA SCI-70 ANTIBODY ELISA received FDA 510(k) clearance on 2011-12-02, under 510(k) number K113143.

Who is the listed applicant for IMMULISA SCI-70 ANTIBODY ELISA?

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

What is the FDA product code for IMMULISA SCI-70 ANTIBODY ELISA?

The FDA product code for IMMULISA SCI-70 ANTIBODY ELISA is LLL.

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Related Devices (Code: LLL)

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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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