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FDA 510(k)

SPQ TEST SYSTEM

K-Number: K982708 · 1999-04-02

ApplicantDiaSorin, Inc.
Decision Date1999-04-02
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPQ TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 1999-04-02 under 510(k) number K982708. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPQ TEST SYSTEM?

SPQ TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1999-04-02. The listed applicant is DiaSorin, Inc.. The 510(k) number is K982708.

When did SPQ TEST SYSTEM receive FDA 510(k) clearance?

SPQ TEST SYSTEM received FDA 510(k) clearance on 1999-04-02, under 510(k) number K982708.

Who is the listed applicant for SPQ TEST SYSTEM?

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

What is the FDA product code for SPQ TEST SYSTEM?

The FDA product code for SPQ TEST SYSTEM is DFC.

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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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