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FDA 510(k)

FERR FLEX REAGENT CARTRIDGE

K-Number: K963498 · 1997-01-24

ApplicantDade Chemistry Systems, Inc.
Decision Date1997-01-24
Product CodeJMG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FERR FLEX REAGENT CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Dade Chemistry Systems, Inc.. It received FDA 510(k) clearance on 1997-01-24 under 510(k) number K963498. The device is classified under product code JMG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FERR FLEX REAGENT CARTRIDGE?

FERR FLEX REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 1997-01-24. The listed applicant is Dade Chemistry Systems, Inc.. The 510(k) number is K963498.

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

FERR FLEX REAGENT CARTRIDGE received FDA 510(k) clearance on 1997-01-24, under 510(k) number K963498.

Who is the listed applicant for FERR FLEX REAGENT CARTRIDGE?

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

What is the FDA product code for FERR FLEX REAGENT CARTRIDGE?

The FDA product code for FERR FLEX REAGENT CARTRIDGE is JMG.

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Other records listing Dade Chemistry Systems, 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.

K973650TROPONIN (TROP) METHODK973100PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATORK973099PROSTATE SPECIFIC ANTIGEN CONTROLK973101PROSTATE SPECIFIC ANTIGEN METHODK971141FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEMK970387HUMAN CHORIONIC GONADOTROPIN METHOD

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K234052Access FerritinBeckman Coulter, Inc.K052082FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020Beckman Coulter, Inc.K964282TINA-QUANT FERRITIN ASSAYBoehringer Mannheim Corp.K971833ELECSYS FERRITINBoehringer Mannheim Corp.K950393ACE(TM) CEDIA(R) FERRITIN ASSAYSchiapparelli Biosystems, Inc.K925848IMMULITE FERRITINDiagnostic Products Corp.

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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