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FDA 510(k)

QUANTA-MATE VITAMIN B-12/FOLATE RA

K-Number: K771047 · 1977-06-27

ApplicantBio-Rad
Decision Date1977-06-27
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTA-MATE VITAMIN B-12/FOLATE RA is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1977-06-27 under 510(k) number K771047. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA-MATE VITAMIN B-12/FOLATE RA?

QUANTA-MATE VITAMIN B-12/FOLATE RA is a medical device that received FDA 510(k) clearance on 1977-06-27. The listed applicant is Bio-Rad. The 510(k) number is K771047.

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

QUANTA-MATE VITAMIN B-12/FOLATE RA received FDA 510(k) clearance on 1977-06-27, under 510(k) number K771047.

Who is the listed applicant for QUANTA-MATE VITAMIN B-12/FOLATE RA?

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-MATE VITAMIN B-12/FOLATE RA?

The FDA product code for QUANTA-MATE VITAMIN B-12/FOLATE RA is CDD.

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Related Devices (Code: CDD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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