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FDA 510(k)

VARELISA M2 ANTIBODIES

K-Number: K945607 · 1995-01-24

ApplicantElias U.S.A., Inc.
Decision Date1995-01-24
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA M2 ANTIBODIES 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 1995-01-24 under 510(k) number K945607. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARELISA M2 ANTIBODIES?

VARELISA M2 ANTIBODIES is a medical device that received FDA 510(k) clearance on 1995-01-24. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K945607.

When did VARELISA M2 ANTIBODIES receive FDA 510(k) clearance?

VARELISA M2 ANTIBODIES received FDA 510(k) clearance on 1995-01-24, under 510(k) number K945607.

Who is the listed applicant for VARELISA M2 ANTIBODIES?

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 M2 ANTIBODIES?

The FDA product code for VARELISA M2 ANTIBODIES is DBM.

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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-ANCAK953586VARELISA PR3-ANCAK951187VARELISA CARDIOLIPIN ABS SCREEN

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Related Devices (Code: DBM)

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.

K181556EliA M2 ImmunoassayPhadia ABK163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsInova Diagnostics, Inc.K163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K092736EUROIMMUN ANTI-M2-3E ELISA (IGG)Euroimmun Us, Inc.K052262QUANTA LITE M2 EP (MIT3) ELISAInova Diagnostics, Inc.K031308RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760Rhigene, 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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