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FDA 510(k)

DIA T1, T2 & T3

K-Number: K842286 · 1984-09-11

ApplicantDiatech, Inc.
Decision Date1984-09-11
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIA T1, T2 & T3 is the device name listed in this FDA 510(k) record. The listed applicant is Diatech, Inc.. It received FDA 510(k) clearance on 1984-09-11 under 510(k) number K842286. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIA T1, T2 & T3?

DIA T1, T2 & T3 is a medical device that received FDA 510(k) clearance on 1984-09-11. The listed applicant is Diatech, Inc.. The 510(k) number is K842286.

When did DIA T1, T2 & T3 receive FDA 510(k) clearance?

DIA T1, T2 & T3 received FDA 510(k) clearance on 1984-09-11, under 510(k) number K842286.

Who is the listed applicant for DIA T1, T2 & T3?

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 T1, T2 & T3?

The FDA product code for DIA T1, T2 & T3 is JPK.

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.K854090DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENTK854089DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENTK841366DIA FIBRINK841365DIA REPTIN

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Related Devices (Code: JPK)

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.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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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