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FDA 510(k)

STA-HYBRID HEP CALIBRATOR

K-Number: K092937 · 2010-08-02

ApplicantDiagnostica Stago, Inc.
Decision Date2010-08-02
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STA-HYBRID HEP CALIBRATOR 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 2010-08-02 under 510(k) number K092937. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STA-HYBRID HEP CALIBRATOR?

STA-HYBRID HEP CALIBRATOR is a medical device that received FDA 510(k) clearance on 2010-08-02. The listed applicant is Diagnostica Stago, Inc.. The 510(k) number is K092937.

When did STA-HYBRID HEP CALIBRATOR receive FDA 510(k) clearance?

STA-HYBRID HEP CALIBRATOR received FDA 510(k) clearance on 2010-08-02, under 510(k) number K092937.

Who is the listed applicant for STA-HYBRID HEP CALIBRATOR?

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-HYBRID HEP CALIBRATOR?

The FDA product code for STA-HYBRID HEP CALIBRATOR is JIT.

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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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