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FDA 510(k)

PHARMACIA CMV IGM ELISA

K-Number: K921011 · 1992-07-27

ApplicantPharmacia Diagnostics, Inc.
Decision Date1992-07-27
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PHARMACIA CMV IGM ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-07-27 under 510(k) number K921011. 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 PHARMACIA CMV IGM ELISA?

PHARMACIA CMV IGM ELISA is a medical device that received FDA 510(k) clearance on 1992-07-27. The listed applicant is Pharmacia Diagnostics, Inc.. The 510(k) number is K921011.

When did PHARMACIA CMV IGM ELISA receive FDA 510(k) clearance?

PHARMACIA CMV IGM ELISA received FDA 510(k) clearance on 1992-07-27, under 510(k) number K921011.

Who is the listed applicant for PHARMACIA CMV IGM ELISA?

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

What is the FDA product code for PHARMACIA CMV IGM ELISA?

The FDA product code for PHARMACIA CMV IGM ELISA is LFZ.

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Other records listing Pharmacia Diagnostics, Inc. as applicant

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.

K920702TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNOK915348EBV-VCA IGM ELISAK914022SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUSK912026DELFIA(R) 17 -OH-PROGESTERON KITK902793RUBELLA IGGK902792TOXOPLASMA GONDII IGG

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Related Devices (Code: LFZ)

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.

K220949Architect CMV IgGAbbott LaboratoriesK220911Elecsys CMV IgGRoche DiagnosticsK181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc.K163569Elecsys CMV IgMRoche DiagnosticsK162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc.K040290DIASORIN LIAISON CMV IGM/IGGDiasorin S.P.A

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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