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FDA 510(k)

HT-110 MICROMINI

K-Number: K782076 · 1978-12-29

ApplicantHealth Tech
Decision Date1978-12-29
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HT-110 MICROMINI is the device name listed in this FDA 510(k) record. The listed applicant is Health Tech. It received FDA 510(k) clearance on 1978-12-29 under 510(k) number K782076. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HT-110 MICROMINI?

HT-110 MICROMINI is a medical device that received FDA 510(k) clearance on 1978-12-29. The listed applicant is Health Tech. The 510(k) number is K782076.

When did HT-110 MICROMINI receive FDA 510(k) clearance?

HT-110 MICROMINI received FDA 510(k) clearance on 1978-12-29, under 510(k) number K782076.

Who is the listed applicant for HT-110 MICROMINI?

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

What is the FDA product code for HT-110 MICROMINI?

The FDA product code for HT-110 MICROMINI is DXH. This falls under the Hematology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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