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FDA 510(k)

RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16

K-Number: K013283 · 2001-11-14

ApplicantImmuno Concepts, Inc.
Decision Date2001-11-14
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 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 2001-11-14 under 510(k) number K013283. 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 RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16?

RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 is a medical device that received FDA 510(k) clearance on 2001-11-14. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K013283.

When did RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 receive FDA 510(k) clearance?

RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 received FDA 510(k) clearance on 2001-11-14, under 510(k) number K013283.

Who is the listed applicant for RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16?

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 RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16?

The FDA product code for RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 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.

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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