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FDA 510(k)

RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11

K-Number: K992041 · 1999-07-23

ApplicantImmuno Concepts, Inc.
Decision Date1999-07-23
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 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 1999-07-23 under 510(k) number K992041. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11?

RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 is a medical device that received FDA 510(k) clearance on 1999-07-23. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K992041.

When did RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 receive FDA 510(k) clearance?

RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 received FDA 510(k) clearance on 1999-07-23, under 510(k) number K992041.

Who is the listed applicant for RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11?

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 ANA SCREENING TEST SYSTEM, MODEL 7096-11?

The FDA product code for RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 is LJM.

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Other records listing Immuno Concepts, Inc. as applicant

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.

K013432IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040GK013285RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15K013283RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16K983924HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-ROK972145HEP-2000 FLUORESCENT ANA-RO TEST SYSTEMK974463IMMUNO CONCEPTS ANCA TEST SYSTEM

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Related Devices (Code: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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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