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FDA 510(k)

FIBRINOGEN TEST

K-Number: K834571 · 1984-02-04

ApplicantDiatech, Inc.
Decision Date1984-02-04
Product CodeKQJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBRINOGEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Diatech, Inc.. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K834571. The device is classified under product code KQJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRINOGEN TEST?

FIBRINOGEN TEST is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Diatech, Inc.. The 510(k) number is K834571.

When did FIBRINOGEN TEST receive FDA 510(k) clearance?

FIBRINOGEN TEST received FDA 510(k) clearance on 1984-02-04, under 510(k) number K834571.

Who is the listed applicant for FIBRINOGEN TEST?

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

What is the FDA product code for FIBRINOGEN TEST?

The FDA product code for FIBRINOGEN TEST is KQJ.

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Other records listing Diatech, 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.

K881685FIBRINOGENTEST-OK854938COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.K854089DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENTK854090DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENTK842286DIA T1, T2 & T3K841365DIA REPTIN

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Related Devices (Code: KQJ)

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.

K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLInstrumentation Laboratory (IL) Co.K073367HEMOSIL FIBRINOGEN-CInstrumentation Laboratory COK050928DADE THROMBIN REAGENTDade Behring, Inc.K971858SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)Sigma Diagnostics, Inc.K970189FIF TMPanbio, Inc.K965113N-ASSAY TIA FIBRINOGEN TEST KITCrestat Diagnostics, 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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