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FDA 510(k)

CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH

K-Number: K123641 · 2013-07-03

ApplicantHertart
Decision Date2013-07-03
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH is the device name listed in this FDA 510(k) record. The listed applicant is Hertart. It received FDA 510(k) clearance on 2013-07-03 under 510(k) number K123641. 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 CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH?

CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH is a medical device that received FDA 510(k) clearance on 2013-07-03. The listed applicant is Hertart. The 510(k) number is K123641.

When did CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH receive FDA 510(k) clearance?

CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH received FDA 510(k) clearance on 2013-07-03, under 510(k) number K123641.

Who is the listed applicant for CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH?

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

What is the FDA product code for CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH?

The FDA product code for CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI 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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