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FDA 510(k)

IMMUNOGLOBULIN A TEST SYSTEM

K-Number: K990552 · 1999-03-25

ApplicantDade Behring, Inc.
Decision Date1999-03-25
Product CodeCFQ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOGLOBULIN A TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 1999-03-25 under 510(k) number K990552. The device is classified under product code CFQ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOGLOBULIN A TEST SYSTEM?

IMMUNOGLOBULIN A TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1999-03-25. The listed applicant is Dade Behring, Inc.. The 510(k) number is K990552.

When did IMMUNOGLOBULIN A TEST SYSTEM receive FDA 510(k) clearance?

IMMUNOGLOBULIN A TEST SYSTEM received FDA 510(k) clearance on 1999-03-25, under 510(k) number K990552.

Who is the listed applicant for IMMUNOGLOBULIN A TEST SYSTEM?

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

What is the FDA product code for IMMUNOGLOBULIN A TEST SYSTEM?

The FDA product code for IMMUNOGLOBULIN A TEST SYSTEM is CFQ.

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Other records listing Dade Behring, Inc. as applicant

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Related Devices (Code: CFQ)

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.

K981786IGA MININEPH ANTISERUMThe Binding Site, Ltd.K990551IGG FLEX REAGENT CARTRIDGEDade Behring, Inc.K990553IGM FLEX REAGENT CARTRIDGEDade Behring, Inc.K951055OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.K951013OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.K950900OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENTOlympus America, 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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