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FDA 510(k)

ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01

K-Number: K072149 · 2008-01-15

ApplicantPhadia US, Inc.
Decision Date2008-01-15
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 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 2008-01-15 under 510(k) number K072149. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01?

ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 is a medical device that received FDA 510(k) clearance on 2008-01-15. The listed applicant is Phadia US, Inc.. The 510(k) number is K072149.

When did ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 receive FDA 510(k) clearance?

ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 received FDA 510(k) clearance on 2008-01-15, under 510(k) number K072149.

Who is the listed applicant for ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01?

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 SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01?

The FDA product code for ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 is LLL.

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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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