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FDA 510(k)

SOFIA(R) HCG FIA

K-Number: K131166 · 2013-08-02

ApplicantQuidel Corp.
Decision Date2013-08-02
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SOFIA(R) HCG FIA is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 2013-08-02 under 510(k) number K131166. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFIA(R) HCG FIA?

SOFIA(R) HCG FIA is a medical device that received FDA 510(k) clearance on 2013-08-02. The listed applicant is Quidel Corp.. The 510(k) number is K131166.

When did SOFIA(R) HCG FIA receive FDA 510(k) clearance?

SOFIA(R) HCG FIA received FDA 510(k) clearance on 2013-08-02, under 510(k) number K131166.

Who is the listed applicant for SOFIA(R) HCG FIA?

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

What is the FDA product code for SOFIA(R) HCG FIA?

The FDA product code for SOFIA(R) HCG FIA is JHI.

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Related Devices (Code: JHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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