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FDA 510(k)

RELISA ENA ANTIBODY SCREENING TEST SYSTEM

K-Number: K935129 · 1994-01-31

ApplicantImmuno Concepts, Inc.
Decision Date1994-01-31
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RELISA ENA ANTIBODY SCREENING TEST SYSTEM 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 1994-01-31 under 510(k) number K935129. 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 RELISA ENA ANTIBODY SCREENING TEST SYSTEM?

RELISA ENA ANTIBODY SCREENING TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1994-01-31. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K935129.

When did RELISA ENA ANTIBODY SCREENING TEST SYSTEM receive FDA 510(k) clearance?

RELISA ENA ANTIBODY SCREENING TEST SYSTEM received FDA 510(k) clearance on 1994-01-31, under 510(k) number K935129.

Who is the listed applicant for RELISA ENA ANTIBODY SCREENING TEST SYSTEM?

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 ENA ANTIBODY SCREENING TEST SYSTEM?

The FDA product code for RELISA ENA ANTIBODY SCREENING TEST SYSTEM is LLL.

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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 # 3040GK013283RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16K013285RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15K992041RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11K983924HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-ROK972145HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM

View all 36 devices →

Related Devices (Code: LLL)

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.

K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems LimitedK253367EliA CTD 13 ScreenPhadia ABK250666Alegria Flash CTD ScreenZeus ScientificK250408Alegria Flash ENA ScreenZeus ScientificK213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.K190710EliA SymphonyS ImmunoassayPhadia AB

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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