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FDA 510(k)

VARELISA ANA (4) PROFILE

K-Number: K963291 · 1996-09-30

ApplicantElias U.S.A., Inc.
Decision Date1996-09-30
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA ANA (4) PROFILE 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 1996-09-30 under 510(k) number K963291. 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 VARELISA ANA (4) PROFILE?

VARELISA ANA (4) PROFILE is a medical device that received FDA 510(k) clearance on 1996-09-30. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K963291.

When did VARELISA ANA (4) PROFILE receive FDA 510(k) clearance?

VARELISA ANA (4) PROFILE received FDA 510(k) clearance on 1996-09-30, under 510(k) number K963291.

Who is the listed applicant for VARELISA ANA (4) PROFILE?

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 ANA (4) PROFILE?

The FDA product code for VARELISA ANA (4) PROFILE is LJM.

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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-2K953873VARELISA HELICOBACTER PYLORI ANTIBODIESK953587VARELISA MPO-ANCAK953586VARELISA PR3-ANCAK951187VARELISA CARDIOLIPIN ABS SCREENK951206VARELISA PARIETAL CELL ANTIBODIES

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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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