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FDA 510(k)

VYSIS D7S486/CEP 7 FISH PROBE KIT

K-Number: K131508 · 2013-09-13

ApplicantAbbott Molecular, Inc.
Decision Date2013-09-13
Product CodePFG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VYSIS D7S486/CEP 7 FISH PROBE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2013-09-13 under 510(k) number K131508. The device is classified under product code PFG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VYSIS D7S486/CEP 7 FISH PROBE KIT?

VYSIS D7S486/CEP 7 FISH PROBE KIT is a medical device that received FDA 510(k) clearance on 2013-09-13. The listed applicant is Abbott Molecular, Inc.. The 510(k) number is K131508.

When did VYSIS D7S486/CEP 7 FISH PROBE KIT receive FDA 510(k) clearance?

VYSIS D7S486/CEP 7 FISH PROBE KIT received FDA 510(k) clearance on 2013-09-13, under 510(k) number K131508.

Who is the listed applicant for VYSIS D7S486/CEP 7 FISH PROBE KIT?

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

What is the FDA product code for VYSIS D7S486/CEP 7 FISH PROBE KIT?

The FDA product code for VYSIS D7S486/CEP 7 FISH PROBE KIT is PFG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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