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FDA 510(k)

HEMOTECT

K-Number: K822731 · 1982-10-18

ApplicantBio-Chem Laboratories
Decision Date1982-10-18
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOTECT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Chem Laboratories. It received FDA 510(k) clearance on 1982-10-18 under 510(k) number K822731. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOTECT?

HEMOTECT is a medical device that received FDA 510(k) clearance on 1982-10-18. The listed applicant is Bio-Chem Laboratories. The 510(k) number is K822731.

When did HEMOTECT receive FDA 510(k) clearance?

HEMOTECT received FDA 510(k) clearance on 1982-10-18, under 510(k) number K822731.

Who is the listed applicant for HEMOTECT?

The FDA 510(k) record lists Bio-Chem Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOTECT?

The FDA product code for HEMOTECT is KHE.

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Other records listing Bio-Chem Laboratories 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.

K902689ATAC 6000 CHEMISTRY ANALYZER

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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.

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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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