FDA 510(k)

VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796

K-Number: K040449 · 2004-05-11

Decision Date2004-05-11

Product CodeMSV

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 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 2004-05-11 under 510(k) number K040449. The device is classified under product code MSV. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796?

VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 is a medical device that received FDA 510(k) clearance on 2004-05-11. The listed applicant is Pharmacia Deutschland GmbH. The 510(k) number is K040449.

When did VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 receive FDA 510(k) clearance?

VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 received FDA 510(k) clearance on 2004-05-11, under 510(k) number K040449.

Who is the listed applicant for VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796?

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 B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796?

The FDA product code for VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 is MSV.

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Other records listing Pharmacia Deutschland GmbH as applicant

K041043VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 K040810VARELISA HISTONE ANTIBODIES, MODEL 16496 K040811VARELISA SSDNA ANTIBODIES, MODEL 14896 K040450VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 K040451VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 K040452VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096

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Related Devices (Code: MSV)

K243979Aptiva APS IgA ReagentInova Diagnostics, Inc.K181329EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayPhadia AB K162788ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYPhadia US, Inc.K091556HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLSInstrumentation Laboratory CO K092757THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCRThera-Test Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.