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FDA 510(k)

VITAMIN B12/FOLATE DUAL RADIOASSAY KITS

K-Number: K812979 · 1981-11-24

ApplicantAmersham Corp.
Decision Date1981-11-24
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITAMIN B12/FOLATE DUAL RADIOASSAY KITS is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1981-11-24 under 510(k) number K812979. 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 VITAMIN B12/FOLATE DUAL RADIOASSAY KITS?

VITAMIN B12/FOLATE DUAL RADIOASSAY KITS is a medical device that received FDA 510(k) clearance on 1981-11-24. The listed applicant is Amersham Corp.. The 510(k) number is K812979.

When did VITAMIN B12/FOLATE DUAL RADIOASSAY KITS receive FDA 510(k) clearance?

VITAMIN B12/FOLATE DUAL RADIOASSAY KITS received FDA 510(k) clearance on 1981-11-24, under 510(k) number K812979.

Who is the listed applicant for VITAMIN B12/FOLATE DUAL RADIOASSAY KITS?

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

What is the FDA product code for VITAMIN B12/FOLATE DUAL RADIOASSAY KITS?

The FDA product code for VITAMIN B12/FOLATE DUAL RADIOASSAY KITS 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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