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FDA 510(k)

PLATELIA LYME IGM

K-Number: K081362 · 2008-06-26

ApplicantBio-Rad
Decision Date2008-06-26
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PLATELIA LYME IGM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2008-06-26 under 510(k) number K081362. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELIA LYME IGM?

PLATELIA LYME IGM is a medical device that received FDA 510(k) clearance on 2008-06-26. The listed applicant is Bio-Rad. The 510(k) number is K081362.

When did PLATELIA LYME IGM receive FDA 510(k) clearance?

PLATELIA LYME IGM received FDA 510(k) clearance on 2008-06-26, under 510(k) number K081362.

Who is the listed applicant for PLATELIA LYME IGM?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLATELIA LYME IGM?

The FDA product code for PLATELIA LYME IGM is LSR.

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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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