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FDA 510(k)

SeraQuest Herpes Type 1 Specific IgG

K-Number: K162276 · 2016-10-01

ApplicantQuest International, Inc.
Decision Date2016-10-01
Product CodeMXJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SeraQuest Herpes Type 1 Specific IgG is the device name listed in this FDA 510(k) record. The listed applicant is Quest International, Inc.. It received FDA 510(k) clearance on 2016-10-01 under 510(k) number K162276. The device is classified under product code MXJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SeraQuest Herpes Type 1 Specific IgG?

SeraQuest Herpes Type 1 Specific IgG is a medical device that received FDA 510(k) clearance on 2016-10-01. The listed applicant is Quest International, Inc.. The 510(k) number is K162276.

When did SeraQuest Herpes Type 1 Specific IgG receive FDA 510(k) clearance?

SeraQuest Herpes Type 1 Specific IgG received FDA 510(k) clearance on 2016-10-01, under 510(k) number K162276.

Who is the listed applicant for SeraQuest Herpes Type 1 Specific IgG?

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

What is the FDA product code for SeraQuest Herpes Type 1 Specific IgG?

The FDA product code for SeraQuest Herpes Type 1 Specific IgG is MXJ.

Other records listing Quest International, Inc. as applicant

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.

K181514SeraQuest HSV Type 2 Specific IgGK152353SeraQuest HSV Type 2 Specific IgG

Related Devices (Code: MXJ)

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.

K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsBiokit, S.A.K220923Elecsys HSV-1 IgG (08948844160)Roche DiagnosticsK181333ADVIA Centaur Herpes-1 IgGBiokit, S.A.

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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