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FDA 510(k)

EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3

K-Number: K061376 · 2006-07-20

Decision Date2006-07-20
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 is the device name listed in this FDA 510(k) record. The listed applicant is Theratest Laboratories, Inc.. It received FDA 510(k) clearance on 2006-07-20 under 510(k) number K061376. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3?

EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 is a medical device that received FDA 510(k) clearance on 2006-07-20. The listed applicant is Theratest Laboratories, Inc.. The 510(k) number is K061376.

When did EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 receive FDA 510(k) clearance?

EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 received FDA 510(k) clearance on 2006-07-20, under 510(k) number K061376.

Who is the listed applicant for EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3?

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

What is the FDA product code for EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3?

The FDA product code for EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 is MOB.

Other records listing Theratest Laboratories, Inc. 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.

View all 22 devices →

Related Devices (Code: MOB)

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.

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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