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FDA 510(k)

VARELISA PR3-ANCA

K-Number: K953586 · 1996-01-26

ApplicantElias U.S.A., Inc.
Decision Date1996-01-26
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA PR3-ANCA 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 1996-01-26 under 510(k) number K953586. 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 VARELISA PR3-ANCA?

VARELISA PR3-ANCA is a medical device that received FDA 510(k) clearance on 1996-01-26. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K953586.

When did VARELISA PR3-ANCA receive FDA 510(k) clearance?

VARELISA PR3-ANCA received FDA 510(k) clearance on 1996-01-26, under 510(k) number K953586.

Who is the listed applicant for VARELISA PR3-ANCA?

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 PR3-ANCA?

The FDA product code for VARELISA PR3-ANCA is MOB.

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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 ANTIBODIESK953587VARELISA MPO-ANCAK951187VARELISA CARDIOLIPIN ABS SCREENK951206VARELISA PARIETAL CELL ANTIBODIES

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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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