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FDA 510(k)

Applied Biosystems Bacillus anthracis Detection Kit

K-Number: K183462 · 2019-10-01

ApplicantMriglobal
Decision Date2019-10-01
Product CodeQIF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Applied Biosystems Bacillus anthracis Detection Kit is the device name listed in this FDA 510(k) record. The listed applicant is Mriglobal. It received FDA 510(k) clearance on 2019-10-01 under 510(k) number K183462. The device is classified under product code QIF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Applied Biosystems Bacillus anthracis Detection Kit?

Applied Biosystems Bacillus anthracis Detection Kit is a medical device that received FDA 510(k) clearance on 2019-10-01. The listed applicant is Mriglobal. The 510(k) number is K183462.

When did Applied Biosystems Bacillus anthracis Detection Kit receive FDA 510(k) clearance?

Applied Biosystems Bacillus anthracis Detection Kit received FDA 510(k) clearance on 2019-10-01, under 510(k) number K183462.

Who is the listed applicant for Applied Biosystems Bacillus anthracis Detection Kit?

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

What is the FDA product code for Applied Biosystems Bacillus anthracis Detection Kit?

The FDA product code for Applied Biosystems Bacillus anthracis Detection Kit is QIF.

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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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