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FDA 510(k)

DIA THROMBIN DIA PLASTIN

K-Number: K840802 · 1984-05-01

ApplicantDiatech, Inc.
Decision Date1984-05-01
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIA THROMBIN DIA PLASTIN is the device name listed in this FDA 510(k) record. The listed applicant is Diatech, Inc.. It received FDA 510(k) clearance on 1984-05-01 under 510(k) number K840802. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIA THROMBIN DIA PLASTIN?

DIA THROMBIN DIA PLASTIN is a medical device that received FDA 510(k) clearance on 1984-05-01. The listed applicant is Diatech, Inc.. The 510(k) number is K840802.

When did DIA THROMBIN DIA PLASTIN receive FDA 510(k) clearance?

DIA THROMBIN DIA PLASTIN received FDA 510(k) clearance on 1984-05-01, under 510(k) number K840802.

Who is the listed applicant for DIA THROMBIN DIA PLASTIN?

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 THROMBIN DIA PLASTIN?

The FDA product code for DIA THROMBIN DIA PLASTIN is GJS.

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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: GJS)

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.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR SystemIline Microsystems, S.L.

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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