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FDA 510(k)

BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH

K-Number: K081896 · 2008-08-20

ApplicantBiogenics, Inc.
Decision Date2008-08-20
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH is the device name listed in this FDA 510(k) record. The listed applicant is Biogenics, Inc.. It received FDA 510(k) clearance on 2008-08-20 under 510(k) number K081896. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH?

BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH is a medical device that received FDA 510(k) clearance on 2008-08-20. The listed applicant is Biogenics, Inc.. The 510(k) number is K081896.

When did BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH receive FDA 510(k) clearance?

BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH received FDA 510(k) clearance on 2008-08-20, under 510(k) number K081896.

Who is the listed applicant for BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH?

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

What is the FDA product code for BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH?

The FDA product code for BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH is MQK.

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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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