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FDA 510(k)

FIBRINOGEN CALIBRATOR KIT

K-Number: K072304 · 2007-09-19

ApplicantDade Behring, Inc.
Decision Date2007-09-19
Product CodeGFX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBRINOGEN CALIBRATOR KIT 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 2007-09-19 under 510(k) number K072304. The device is classified under product code GFX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRINOGEN CALIBRATOR KIT?

FIBRINOGEN CALIBRATOR KIT is a medical device that received FDA 510(k) clearance on 2007-09-19. The listed applicant is Dade Behring, Inc.. The 510(k) number is K072304.

When did FIBRINOGEN CALIBRATOR KIT receive FDA 510(k) clearance?

FIBRINOGEN CALIBRATOR KIT received FDA 510(k) clearance on 2007-09-19, under 510(k) number K072304.

Who is the listed applicant for FIBRINOGEN CALIBRATOR KIT?

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 FIBRINOGEN CALIBRATOR KIT?

The FDA product code for FIBRINOGEN CALIBRATOR KIT is GFX.

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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: GFX)

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.

K994341FIBRINOGEN CALIBRATOR KITDade Behring, Inc.K812628ACA FIBRINOGEN CALIBRATORE.I. Dupont DE Nemours & Co., 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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