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FDA 510(k)

PRESAGE ST2 ASSAY

K-Number: K111452 · 2011-12-09

ApplicantCritical Care Diagnostics, Inc. (Dba Critical Diag
Decision Date2011-12-09
Product CodeOYG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRESAGE ST2 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Critical Care Diagnostics, Inc. (Dba Critical Diag. It received FDA 510(k) clearance on 2011-12-09 under 510(k) number K111452. The device is classified under product code OYG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESAGE ST2 ASSAY?

PRESAGE ST2 ASSAY is a medical device that received FDA 510(k) clearance on 2011-12-09. The listed applicant is Critical Care Diagnostics, Inc. (Dba Critical Diag. The 510(k) number is K111452.

When did PRESAGE ST2 ASSAY receive FDA 510(k) clearance?

PRESAGE ST2 ASSAY received FDA 510(k) clearance on 2011-12-09, under 510(k) number K111452.

Who is the listed applicant for PRESAGE ST2 ASSAY?

The FDA 510(k) record lists Critical Care Diagnostics, Inc. (Dba Critical Diag as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESAGE ST2 ASSAY?

The FDA product code for PRESAGE ST2 ASSAY is OYG.

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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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