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FDA 510(k)

IMMULISA ANCA SCREEN ELISA

K-Number: K092601 · 2010-10-07

ApplicantImmco Diagnostics, Inc.
Decision Date2010-10-07
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULISA ANCA SCREEN 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 2010-10-07 under 510(k) number K092601. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULISA ANCA SCREEN ELISA?

IMMULISA ANCA SCREEN ELISA is a medical device that received FDA 510(k) clearance on 2010-10-07. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K092601.

When did IMMULISA ANCA SCREEN ELISA receive FDA 510(k) clearance?

IMMULISA ANCA SCREEN ELISA received FDA 510(k) clearance on 2010-10-07, under 510(k) number K092601.

Who is the listed applicant for IMMULISA ANCA SCREEN 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 ANCA SCREEN ELISA?

The FDA product code for IMMULISA ANCA SCREEN ELISA is MOB.

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Related Devices (Code: MOB)

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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