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FDA 510(k)

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

K-Number: K151426 · 2016-01-29

ApplicantScandidos AB
Decision Date2016-01-29
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ is the device name listed in this FDA 510(k) record. The listed applicant is Scandidos AB. It received FDA 510(k) clearance on 2016-01-29 under 510(k) number K151426. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+?

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is Scandidos AB. The 510(k) number is K151426.

When did ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ receive FDA 510(k) clearance?

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ received FDA 510(k) clearance on 2016-01-29, under 510(k) number K151426.

Who is the listed applicant for ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+?

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

What is the FDA product code for ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+?

The FDA product code for ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ is IYE.

Other records listing Scandidos AB 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.

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Related Devices (Code: IYE)

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

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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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