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FDA 510(k)

BARTELS CYTOMEGALOVIRUS IGG EIA

K-Number: K922582 · 1993-04-08

ApplicantBaxter Diagnostics, Inc.
Decision Date1993-04-08
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BARTELS CYTOMEGALOVIRUS IGG EIA is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-04-08 under 510(k) number K922582. 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 BARTELS CYTOMEGALOVIRUS IGG EIA?

BARTELS CYTOMEGALOVIRUS IGG EIA is a medical device that received FDA 510(k) clearance on 1993-04-08. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K922582.

When did BARTELS CYTOMEGALOVIRUS IGG EIA receive FDA 510(k) clearance?

BARTELS CYTOMEGALOVIRUS IGG EIA received FDA 510(k) clearance on 1993-04-08, under 510(k) number K922582.

Who is the listed applicant for BARTELS CYTOMEGALOVIRUS IGG EIA?

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

What is the FDA product code for BARTELS CYTOMEGALOVIRUS IGG EIA?

The FDA product code for BARTELS CYTOMEGALOVIRUS IGG EIA is 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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