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FDA 510(k)

STA-CEPHASCREEN KIT

K-Number: K053111 · 2006-05-04

ApplicantDiagnostica Stago, Inc.
Decision Date2006-05-04
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STA-CEPHASCREEN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica Stago, Inc.. It received FDA 510(k) clearance on 2006-05-04 under 510(k) number K053111. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STA-CEPHASCREEN KIT?

STA-CEPHASCREEN KIT is a medical device that received FDA 510(k) clearance on 2006-05-04. The listed applicant is Diagnostica Stago, Inc.. The 510(k) number is K053111.

When did STA-CEPHASCREEN KIT receive FDA 510(k) clearance?

STA-CEPHASCREEN KIT received FDA 510(k) clearance on 2006-05-04, under 510(k) number K053111.

Who is the listed applicant for STA-CEPHASCREEN KIT?

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

What is the FDA product code for STA-CEPHASCREEN KIT?

The FDA product code for STA-CEPHASCREEN KIT is GFO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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