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FDA 510(k)

IGM FLEX REAGENT CARTRIDGE

K-Number: K990553 · 1999-03-22

ApplicantDade Behring, Inc.
Decision Date1999-03-22
Product CodeCFQ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IGM FLEX REAGENT CARTRIDGE 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 1999-03-22 under 510(k) number K990553. 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 IGM FLEX REAGENT CARTRIDGE?

IGM FLEX REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 1999-03-22. The listed applicant is Dade Behring, Inc.. The 510(k) number is K990553.

When did IGM FLEX REAGENT CARTRIDGE receive FDA 510(k) clearance?

IGM FLEX REAGENT CARTRIDGE received FDA 510(k) clearance on 1999-03-22, under 510(k) number K990553.

Who is the listed applicant for IGM FLEX REAGENT CARTRIDGE?

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 IGM FLEX REAGENT CARTRIDGE?

The FDA product code for IGM FLEX REAGENT CARTRIDGE is CFQ.

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Other records listing Dade Behring, 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.

K093848PT-MULTI-CALIBRATOR, MODEL OPAT07K081161DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYSTK081249DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEMK071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600K073604DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

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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.K990552IMMUNOGLOBULIN A TEST SYSTEMDade 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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