FDA 510(k)

MDx-Chex for BCID2

K-Number: K212576 · 2022-01-19

Decision Date2022-01-19

Product CodePMN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MDx-Chex for BCID2 is a medical device manufactured by Streck, Inc.. It received FDA 510(k) clearance on 2022-01-19 under approval number K212576. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MDx-Chex for BCID2?

MDx-Chex for BCID2 is a medical device that received FDA 510(k) clearance on 2022-01-19. It is manufactured by Streck, Inc.. The 510(k) number is K212576.

When was MDx-Chex for BCID2 approved by the FDA?

MDx-Chex for BCID2 received FDA 510(k) clearance on 2022-01-19, under approval number K212576.

What company makes MDx-Chex for BCID2?

MDx-Chex for BCID2 is manufactured by Streck, Inc..

What is the FDA product code for MDx-Chex for BCID2?

The FDA product code for MDx-Chex for BCID2 is PMN.

Other Devices by Streck, Inc.

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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.