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FDA 510(k)

BIO-RAD PLATELIA TOXO IGM TMB

K-Number: K013837 · 2002-09-30

ApplicantBio-Rad
Decision Date2002-09-30
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIO-RAD PLATELIA TOXO IGM TMB is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2002-09-30 under 510(k) number K013837. 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 BIO-RAD PLATELIA TOXO IGM TMB?

BIO-RAD PLATELIA TOXO IGM TMB is a medical device that received FDA 510(k) clearance on 2002-09-30. The listed applicant is Bio-Rad. The 510(k) number is K013837.

When did BIO-RAD PLATELIA TOXO IGM TMB receive FDA 510(k) clearance?

BIO-RAD PLATELIA TOXO IGM TMB received FDA 510(k) clearance on 2002-09-30, under 510(k) number K013837.

Who is the listed applicant for BIO-RAD PLATELIA TOXO IGM TMB?

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 BIO-RAD PLATELIA TOXO IGM TMB?

The FDA product code for BIO-RAD PLATELIA TOXO IGM TMB is LGD.

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Related Devices (Code: LGD)

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.

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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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