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FDA 510(k)

BlastGen

K-Number: K152932 · 2016-02-29

ApplicantOrigio A/S
Decision Date2016-02-29
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BlastGen is the device name listed in this FDA 510(k) record. The listed applicant is Origio A/S. It received FDA 510(k) clearance on 2016-02-29 under 510(k) number K152932. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BlastGen?

BlastGen is a medical device that received FDA 510(k) clearance on 2016-02-29. The listed applicant is Origio A/S. The 510(k) number is K152932.

When did BlastGen receive FDA 510(k) clearance?

BlastGen received FDA 510(k) clearance on 2016-02-29, under 510(k) number K152932.

Who is the listed applicant for BlastGen?

The FDA 510(k) record lists Origio A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BlastGen?

The FDA product code for BlastGen is MQL.

Other records listing Origio A/S 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: MQL)

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.

K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato CorporationK242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV

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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