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FDA 510(k)

PLATELIA TOXO IGM KIT MODEL 26211

K-Number: K090847 · 2009-07-01

ApplicantBio-Rad Laboratories
Decision Date2009-07-01
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PLATELIA TOXO IGM KIT MODEL 26211 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories. It received FDA 510(k) clearance on 2009-07-01 under 510(k) number K090847. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELIA TOXO IGM KIT MODEL 26211?

PLATELIA TOXO IGM KIT MODEL 26211 is a medical device that received FDA 510(k) clearance on 2009-07-01. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K090847.

When did PLATELIA TOXO IGM KIT MODEL 26211 receive FDA 510(k) clearance?

PLATELIA TOXO IGM KIT MODEL 26211 received FDA 510(k) clearance on 2009-07-01, under 510(k) number K090847.

Who is the listed applicant for PLATELIA TOXO IGM KIT MODEL 26211?

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

What is the FDA product code for PLATELIA TOXO IGM KIT MODEL 26211?

The FDA product code for PLATELIA TOXO IGM KIT MODEL 26211 is LGD.

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Related Devices (Code: LGD)

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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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