FDA 510(k)

ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01

K-Number: K062583 · 2006-12-26

Decision Date2006-12-26

Product CodeMVM

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 is the device name listed in this FDA 510(k) record. The listed applicant is Phadia US, Inc.. It received FDA 510(k) clearance on 2006-12-26 under 510(k) number K062583. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01?

ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 is a medical device that received FDA 510(k) clearance on 2006-12-26. The listed applicant is Phadia US, Inc.. The 510(k) number is K062583.

When did ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 receive FDA 510(k) clearance?

ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 received FDA 510(k) clearance on 2006-12-26, under 510(k) number K062583.

Who is the listed applicant for ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01?

The FDA 510(k) record lists Phadia US, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01?

The FDA product code for ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 is MVM.

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Other records listing Phadia US, Inc. as applicant

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Related Devices (Code: MVM)

K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc.K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc.K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG ImmunoassayPhadia AB K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)Euroimmun Us, Inc.K123713IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISAImmco Diagnostics, Inc.K130053BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BIBio-Rad Laboratories, 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.