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FDA 510(k)

BIOPLUS

K-Number: K042636 · 2004-12-14

ApplicantBerkeley Advanced Biomaterials, Inc.
Decision Date2004-12-14
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOPLUS is the device name listed in this FDA 510(k) record. The listed applicant is Berkeley Advanced Biomaterials, Inc.. It received FDA 510(k) clearance on 2004-12-14 under 510(k) number K042636. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPLUS?

BIOPLUS is a medical device that received FDA 510(k) clearance on 2004-12-14. The listed applicant is Berkeley Advanced Biomaterials, Inc.. The 510(k) number is K042636.

When did BIOPLUS receive FDA 510(k) clearance?

BIOPLUS received FDA 510(k) clearance on 2004-12-14, under 510(k) number K042636.

Who is the listed applicant for BIOPLUS?

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

What is the FDA product code for BIOPLUS?

The FDA product code for BIOPLUS is MQV.

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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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