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FDA 510(k)

N-ASSAY TIA IGA

K-Number: K933971 · 1994-03-22

ApplicantCrestat Diagnostics, Inc.
Decision Date1994-03-22
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N-ASSAY TIA IGA is the device name listed in this FDA 510(k) record. The listed applicant is Crestat Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-03-22 under 510(k) number K933971. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N-ASSAY TIA IGA?

N-ASSAY TIA IGA is a medical device that received FDA 510(k) clearance on 1994-03-22. The listed applicant is Crestat Diagnostics, Inc.. The 510(k) number is K933971.

When did N-ASSAY TIA IGA receive FDA 510(k) clearance?

N-ASSAY TIA IGA received FDA 510(k) clearance on 1994-03-22, under 510(k) number K933971.

Who is the listed applicant for N-ASSAY TIA IGA?

The FDA 510(k) record lists Crestat Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N-ASSAY TIA IGA?

The FDA product code for N-ASSAY TIA IGA is CFN.

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Related Devices (Code: CFN)

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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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