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FDA 510(k)

DIA-H 1/2/3 & DIA-HT 1/2/3

K-Number: K840801 · 1984-04-25

ApplicantDiatech, Inc.
Decision Date1984-04-25
Product Code
DecisionSubstantially Equivalent

Device Summary

DIA-H 1/2/3 & DIA-HT 1/2/3 is the device name listed in this FDA 510(k) record. The listed applicant is Diatech, Inc.. It received FDA 510(k) clearance on 1984-04-25 under 510(k) number K840801. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIA-H 1/2/3 & DIA-HT 1/2/3?

DIA-H 1/2/3 & DIA-HT 1/2/3 is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Diatech, Inc.. The 510(k) number is K840801.

When did DIA-H 1/2/3 & DIA-HT 1/2/3 receive FDA 510(k) clearance?

DIA-H 1/2/3 & DIA-HT 1/2/3 received FDA 510(k) clearance on 1984-04-25, under 510(k) number K840801.

Who is the listed applicant for DIA-H 1/2/3 & DIA-HT 1/2/3?

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

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

View all 17 devices →

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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