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FDA 510(k)

MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711

K-Number: K100336 · 2010-05-12

ApplicantEragen Biosciences
Decision Date2010-05-12
Product CodeOQO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 is the device name listed in this FDA 510(k) record. The listed applicant is Eragen Biosciences. It received FDA 510(k) clearance on 2010-05-12 under 510(k) number K100336. The device is classified under product code OQO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711?

MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 is a medical device that received FDA 510(k) clearance on 2010-05-12. The listed applicant is Eragen Biosciences. The 510(k) number is K100336.

When did MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 receive FDA 510(k) clearance?

MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 received FDA 510(k) clearance on 2010-05-12, under 510(k) number K100336.

Who is the listed applicant for MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711?

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

What is the FDA product code for MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711?

The FDA product code for MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 is OQO.

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Related Devices (Code: OQO)

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.

K172509Sentosa SA201 HSV 1/2 Qualitative PCR TestVela Diagnostics USA, Inc.K162673Aptima Herpes Simplex Viruses 1 & 2 AssayHologic, Inc.K111951ISOAMP HSV ASSAYBiohelix CorporationK111527MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KITEragen Biosciences, Inc.K103798BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYSBecton, Dickinson & CO

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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