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FDA 510(k)

VARELISA SM ANTIBODIES, MODEL 18296

K-Number: K042629 · 2004-12-08

ApplicantSweden Diagnostics (Germany) GmbH
Decision Date2004-12-08
Product CodeLKP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA SM ANTIBODIES, MODEL 18296 is the device name listed in this FDA 510(k) record. The listed applicant is Sweden Diagnostics (Germany) GmbH. It received FDA 510(k) clearance on 2004-12-08 under 510(k) number K042629. The device is classified under product code LKP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARELISA SM ANTIBODIES, MODEL 18296?

VARELISA SM ANTIBODIES, MODEL 18296 is a medical device that received FDA 510(k) clearance on 2004-12-08. The listed applicant is Sweden Diagnostics (Germany) GmbH. The 510(k) number is K042629.

When did VARELISA SM ANTIBODIES, MODEL 18296 receive FDA 510(k) clearance?

VARELISA SM ANTIBODIES, MODEL 18296 received FDA 510(k) clearance on 2004-12-08, under 510(k) number K042629.

Who is the listed applicant for VARELISA SM ANTIBODIES, MODEL 18296?

The FDA 510(k) record lists Sweden Diagnostics (Germany) GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARELISA SM ANTIBODIES, MODEL 18296?

The FDA product code for VARELISA SM ANTIBODIES, MODEL 18296 is LKP.

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Other records listing Sweden Diagnostics (Germany) GmbH 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.

K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096K050625VARELISA RECOMBI ANA PROFILE, MODEL 18496K041357VARELISA GLIADIN IGG ANTIBODIESK041173CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996K041174CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196K041354VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896

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Related Devices (Code: LKP)

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.

K202067EliA SmDP-SPhadia ABK183007EliA SmDP ImmunoassayPhadia ABK123593QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,Inova Diagnostics, Inc.K051066THERATEST EL-ANA PROFILESTheratest Laboratories, Inc.K024219LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115Bio-RadK013263FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TESTFred Hutchinson Cancer Research Center

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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