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FDA 510(k)

VARELISA COMBINED DNA ANTIBODIES EIA

K-Number: K944334 · 1995-04-17

ApplicantElias U.S.A., Inc.
Decision Date1995-04-17
Product CodeLRM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA COMBINED DNA ANTIBODIES EIA is the device name listed in this FDA 510(k) record. The listed applicant is Elias U.S.A., Inc.. It received FDA 510(k) clearance on 1995-04-17 under 510(k) number K944334. The device is classified under product code LRM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARELISA COMBINED DNA ANTIBODIES EIA?

VARELISA COMBINED DNA ANTIBODIES EIA is a medical device that received FDA 510(k) clearance on 1995-04-17. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K944334.

When did VARELISA COMBINED DNA ANTIBODIES EIA receive FDA 510(k) clearance?

VARELISA COMBINED DNA ANTIBODIES EIA received FDA 510(k) clearance on 1995-04-17, under 510(k) number K944334.

Who is the listed applicant for VARELISA COMBINED DNA ANTIBODIES EIA?

The FDA 510(k) record lists Elias U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARELISA COMBINED DNA ANTIBODIES EIA?

The FDA product code for VARELISA COMBINED DNA ANTIBODIES EIA is LRM.

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Other records listing Elias U.S.A., 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.

K964385ELIAS ANA-HEP-2K963291VARELISA ANA (4) PROFILEK953873VARELISA HELICOBACTER PYLORI ANTIBODIESK953586VARELISA PR3-ANCAK953587VARELISA MPO-ANCAK951187VARELISA CARDIOLIPIN ABS SCREEN

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Related Devices (Code: LRM)

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.

K101319IMMULISA DSDNA ANTIBODY ELISAImmco Diagnostics, Inc.K083381EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)Euroimmun Us, Inc.K062183FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KITThe Binding Site, Ltd.K040811VARELISA SSDNA ANTIBODIES, MODEL 14896Pharmacia Deutschland GmbHK001900ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTHelix Diagnostics, Inc.K000477MDI DS-DNA TESTMicro Detect, 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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