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FDA 510(k)

DIA FIBRIN

K-Number: K841366 · 1984-06-01

ApplicantDiatech, Inc.
Decision Date1984-06-01
Product CodeKQJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIA FIBRIN is the device name listed in this FDA 510(k) record. The listed applicant is Diatech, Inc.. It received FDA 510(k) clearance on 1984-06-01 under 510(k) number K841366. 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 DIA FIBRIN?

DIA FIBRIN is a medical device that received FDA 510(k) clearance on 1984-06-01. The listed applicant is Diatech, Inc.. The 510(k) number is K841366.

When did DIA FIBRIN receive FDA 510(k) clearance?

DIA FIBRIN received FDA 510(k) clearance on 1984-06-01, under 510(k) number K841366.

Who is the listed applicant for DIA FIBRIN?

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 DIA FIBRIN?

The FDA product code for DIA FIBRIN 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 & T3K841523OWREN'S VERONAL BUFFERR

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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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