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FDA 510(k)

THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR

K-Number: K092757 · 2009-10-09

ApplicantThera-Test Laboratories, Inc.
Decision Date2009-10-09
Product CodeMSV
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR is the device name listed in this FDA 510(k) record. The listed applicant is Thera-Test Laboratories, Inc.. It received FDA 510(k) clearance on 2009-10-09 under 510(k) number K092757. 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 THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR?

THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR is a medical device that received FDA 510(k) clearance on 2009-10-09. The listed applicant is Thera-Test Laboratories, Inc.. The 510(k) number is K092757.

When did THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR receive FDA 510(k) clearance?

THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR received FDA 510(k) clearance on 2009-10-09, under 510(k) number K092757.

Who is the listed applicant for THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR?

The FDA 510(k) record lists Thera-Test Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR?

The FDA product code for THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR is MSV.

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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.

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