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FDA 510(k)

MONOLISA ANTI-HAV EIA

K-Number: K063318 · 2007-05-03

ApplicantBio-Rad Laboratories
Decision Date2007-05-03
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MONOLISA ANTI-HAV EIA 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 2007-05-03 under 510(k) number K063318. The device is classified under product code LOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOLISA ANTI-HAV EIA?

MONOLISA ANTI-HAV EIA is a medical device that received FDA 510(k) clearance on 2007-05-03. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K063318.

When did MONOLISA ANTI-HAV EIA receive FDA 510(k) clearance?

MONOLISA ANTI-HAV EIA received FDA 510(k) clearance on 2007-05-03, under 510(k) number K063318.

Who is the listed applicant for MONOLISA ANTI-HAV EIA?

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 MONOLISA ANTI-HAV EIA?

The FDA product code for MONOLISA ANTI-HAV EIA is LOL.

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Related Devices (Code: LOL)

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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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