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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 a medical device manufactured by Mriglobal. It received FDA 510(k) clearance on 2019-10-01 under approval 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. It is manufactured by Mriglobal. The 510(k) number is K183462.

When was Applied Biosystems Bacillus anthracis Detection Kit approved by the FDA?

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

What company makes Applied Biosystems Bacillus anthracis Detection Kit?

Applied Biosystems Bacillus anthracis Detection Kit is manufactured by Mriglobal.

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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