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FDA 510(k)

CEDIA(R) FOLATE (NO BOIL) ASSAY

K-Number: K946184 · 1995-01-17

ApplicantMicrogenics Corp.
Decision Date1995-01-17
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CEDIA(R) FOLATE (NO BOIL) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 1995-01-17 under 510(k) number K946184. 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 CEDIA(R) FOLATE (NO BOIL) ASSAY?

CEDIA(R) FOLATE (NO BOIL) ASSAY is a medical device that received FDA 510(k) clearance on 1995-01-17. The listed applicant is Microgenics Corp.. The 510(k) number is K946184.

When did CEDIA(R) FOLATE (NO BOIL) ASSAY receive FDA 510(k) clearance?

CEDIA(R) FOLATE (NO BOIL) ASSAY received FDA 510(k) clearance on 1995-01-17, under 510(k) number K946184.

Who is the listed applicant for CEDIA(R) FOLATE (NO BOIL) ASSAY?

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

What is the FDA product code for CEDIA(R) FOLATE (NO BOIL) ASSAY?

The FDA product code for CEDIA(R) FOLATE (NO BOIL) ASSAY 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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