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FDA 510(k)

IMMUNO CONCEPTS ANCA TEST SYSTEMS

K-Number: K974478 · 1998-02-09

ApplicantImmuno Concepts, Inc.
Decision Date1998-02-09
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNO CONCEPTS ANCA TEST SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Concepts, Inc.. It received FDA 510(k) clearance on 1998-02-09 under 510(k) number K974478. 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 IMMUNO CONCEPTS ANCA TEST SYSTEMS?

IMMUNO CONCEPTS ANCA TEST SYSTEMS is a medical device that received FDA 510(k) clearance on 1998-02-09. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K974478.

When did IMMUNO CONCEPTS ANCA TEST SYSTEMS receive FDA 510(k) clearance?

IMMUNO CONCEPTS ANCA TEST SYSTEMS received FDA 510(k) clearance on 1998-02-09, under 510(k) number K974478.

Who is the listed applicant for IMMUNO CONCEPTS ANCA TEST SYSTEMS?

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

What is the FDA product code for IMMUNO CONCEPTS ANCA TEST SYSTEMS?

The FDA product code for IMMUNO CONCEPTS ANCA TEST SYSTEMS is MOB.

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Other records listing Immuno Concepts, Inc. as applicant

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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.

K261466Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMZeus ScientificK243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)Zeus ScientificK172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternEuroimmun Us, Inc.K172461AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinAesku.Diagnostics GmbH & Co. KGK173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia ABK161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova Diagnostics, 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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