FDA 510(k)

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0

K-Number: K234091 · 2024-07-22

Decision Date2024-07-22

Product CodeJLW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 is a medical device manufactured by Genalyte, Inc.. It received FDA 510(k) clearance on 2024-07-22 under approval number K234091. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0?

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 is a medical device that received FDA 510(k) clearance on 2024-07-22. It is manufactured by Genalyte, Inc.. The 510(k) number is K234091.

When was Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 approved by the FDA?

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 received FDA 510(k) clearance on 2024-07-22, under approval number K234091.

What company makes Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0?

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 is manufactured by Genalyte, Inc..

What is the FDA product code for Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0?

The FDA product code for Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 is JLW.

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Other Devices by Genalyte, Inc.

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Official Source

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