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FDA 510(k)

HEMO-ALERT

K-Number: K893830 · 1989-10-12

ApplicantKoregon Enterprise, Inc.
Decision Date1989-10-12
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEMO-ALERT is the device name listed in this FDA 510(k) record. The listed applicant is Koregon Enterprise, Inc.. It received FDA 510(k) clearance on 1989-10-12 under 510(k) number K893830. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMO-ALERT?

HEMO-ALERT is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Koregon Enterprise, Inc.. The 510(k) number is K893830.

When did HEMO-ALERT receive FDA 510(k) clearance?

HEMO-ALERT received FDA 510(k) clearance on 1989-10-12, under 510(k) number K893830.

Who is the listed applicant for HEMO-ALERT?

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

What is the FDA product code for HEMO-ALERT?

The FDA product code for HEMO-ALERT is DQO.

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Related Devices (Code: DQO)

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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