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FDA 510(k)

ISOAMP HSV ASSAY

K-Number: K111951 · 2011-09-27

ApplicantBiohelix Corporation
Decision Date2011-09-27
Product CodeOQO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ISOAMP HSV ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Biohelix Corporation. It received FDA 510(k) clearance on 2011-09-27 under 510(k) number K111951. 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 ISOAMP HSV ASSAY?

ISOAMP HSV ASSAY is a medical device that received FDA 510(k) clearance on 2011-09-27. The listed applicant is Biohelix Corporation. The 510(k) number is K111951.

When did ISOAMP HSV ASSAY receive FDA 510(k) clearance?

ISOAMP HSV ASSAY received FDA 510(k) clearance on 2011-09-27, under 510(k) number K111951.

Who is the listed applicant for ISOAMP HSV ASSAY?

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

What is the FDA product code for ISOAMP HSV ASSAY?

The FDA product code for ISOAMP HSV ASSAY 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.K111527MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KITEragen Biosciences, Inc.K103798BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYSBecton, Dickinson & COK100336MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711Eragen Biosciences

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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