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FDA 510(k)

FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES

K-Number: K863798 · 1987-04-14

ApplicantWhittaker Bioproducts, Inc.
Decision Date1987-04-14
Product CodeLKQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1987-04-14 under 510(k) number K863798. The device is classified under product code LKQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES?

FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES is a medical device that received FDA 510(k) clearance on 1987-04-14. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K863798.

When did FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES receive FDA 510(k) clearance?

FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES received FDA 510(k) clearance on 1987-04-14, under 510(k) number K863798.

Who is the listed applicant for FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES?

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

What is the FDA product code for FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES?

The FDA product code for FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES is LKQ.

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Other records listing Whittaker Bioproducts, Inc. as applicant

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Related Devices (Code: LKQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K100433IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,Siemens Healthcare DiagnosticsK972884ACCURUN 146 CMV IGM POSITIVE CONTROLBoston Biomedica, Inc.K933549VIDAS CMV IGM ASSAYBiomerieux Vitek, Inc.K922580BARTELS CYTOMEGALOVIRUS IGM EIABaxter Diagnostics, Inc.K914789ELISA CMV IGMSclavo, Inc.K913080OPUS(R) ANTI CMV-MPb Diagnostics, Inc.

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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