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FDA 510(k)

QUANTAPHASE II B12/FOLATE

K-Number: K935286 · 1994-02-18

ApplicantBio-Rad
Decision Date1994-02-18
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTAPHASE II B12/FOLATE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1994-02-18 under 510(k) number K935286. 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 QUANTAPHASE II B12/FOLATE?

QUANTAPHASE II B12/FOLATE is a medical device that received FDA 510(k) clearance on 1994-02-18. The listed applicant is Bio-Rad. The 510(k) number is K935286.

When did QUANTAPHASE II B12/FOLATE receive FDA 510(k) clearance?

QUANTAPHASE II B12/FOLATE received FDA 510(k) clearance on 1994-02-18, under 510(k) number K935286.

Who is the listed applicant for QUANTAPHASE II B12/FOLATE?

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 QUANTAPHASE II B12/FOLATE?

The FDA product code for QUANTAPHASE II B12/FOLATE 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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