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FDA 510(k)

ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)

K-Number: K954301 · 1997-03-24

ApplicantAbbott Laboratories
Decision Date1997-03-24
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1997-03-24 under 510(k) number K954301. The device is classified under product code LFZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)?

ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1997-03-24. The listed applicant is Abbott Laboratories. The 510(k) number is K954301.

When did ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) receive FDA 510(k) clearance?

ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) received FDA 510(k) clearance on 1997-03-24, under 510(k) number K954301.

Who is the listed applicant for ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)?

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

What is the FDA product code for ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)?

The FDA product code for ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) is LFZ.

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Related Devices (Code: LFZ)

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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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