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FDA 510(k)

VARELISA SSDNA ANTIBODIES, MODEL 14896

K-Number: K040811 · 2004-05-13

ApplicantPharmacia Deutschland GmbH
Decision Date2004-05-13
Product CodeLRM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA SSDNA ANTIBODIES, MODEL 14896 is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Deutschland GmbH. It received FDA 510(k) clearance on 2004-05-13 under 510(k) number K040811. 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 SSDNA ANTIBODIES, MODEL 14896?

VARELISA SSDNA ANTIBODIES, MODEL 14896 is a medical device that received FDA 510(k) clearance on 2004-05-13. The listed applicant is Pharmacia Deutschland GmbH. The 510(k) number is K040811.

When did VARELISA SSDNA ANTIBODIES, MODEL 14896 receive FDA 510(k) clearance?

VARELISA SSDNA ANTIBODIES, MODEL 14896 received FDA 510(k) clearance on 2004-05-13, under 510(k) number K040811.

Who is the listed applicant for VARELISA SSDNA ANTIBODIES, MODEL 14896?

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

What is the FDA product code for VARELISA SSDNA ANTIBODIES, MODEL 14896?

The FDA product code for VARELISA SSDNA ANTIBODIES, MODEL 14896 is LRM.

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Other records listing Pharmacia Deutschland 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.

K041043VARELISA PR3 ANCA, MODEL NUMBER 17748/17796K040810VARELISA HISTONE ANTIBODIES, MODEL 16496K040449VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796K040451VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896K040452VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096K040450VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996

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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.K001900ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTHelix Diagnostics, Inc.K000477MDI DS-DNA TESTMicro Detect, Inc.K994424DIAMEDIX IS-ANTI-DSDNA TEST SYSTEMDiamedix Corp.

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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