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FDA 510(k)

QUANTA PHASE VITAMIN B-12/FOLATE RAD

K-Number: K811177 · 1981-05-15

ApplicantBio-Rad
Decision Date1981-05-15
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTA PHASE VITAMIN B-12/FOLATE RAD is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1981-05-15 under 510(k) number K811177. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA PHASE VITAMIN B-12/FOLATE RAD?

QUANTA PHASE VITAMIN B-12/FOLATE RAD is a medical device that received FDA 510(k) clearance on 1981-05-15. The listed applicant is Bio-Rad. The 510(k) number is K811177.

When did QUANTA PHASE VITAMIN B-12/FOLATE RAD receive FDA 510(k) clearance?

QUANTA PHASE VITAMIN B-12/FOLATE RAD received FDA 510(k) clearance on 1981-05-15, under 510(k) number K811177.

Who is the listed applicant for QUANTA PHASE VITAMIN B-12/FOLATE RAD?

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

What is the FDA product code for QUANTA PHASE VITAMIN B-12/FOLATE RAD?

The FDA product code for QUANTA PHASE VITAMIN B-12/FOLATE RAD is CGN.

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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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