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FDA 510(k)

ANA-SCREEN WITH MDSS

K-Number: K113610 · 2012-07-09

ApplicantBio-Rad Laboratories
Decision Date2012-07-09
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANA-SCREEN WITH MDSS is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories. It received FDA 510(k) clearance on 2012-07-09 under 510(k) number K113610. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANA-SCREEN WITH MDSS?

ANA-SCREEN WITH MDSS is a medical device that received FDA 510(k) clearance on 2012-07-09. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K113610.

When did ANA-SCREEN WITH MDSS receive FDA 510(k) clearance?

ANA-SCREEN WITH MDSS received FDA 510(k) clearance on 2012-07-09, under 510(k) number K113610.

Who is the listed applicant for ANA-SCREEN WITH MDSS?

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

What is the FDA product code for ANA-SCREEN WITH MDSS?

The FDA product code for ANA-SCREEN WITH MDSS is LKJ.

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Related Devices (Code: LKJ)

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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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