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FDA 510(k)

HEMAGEN ENA [JO-I] KIT

K-Number: K902139 · 1990-05-18

ApplicantHemagen Diagnostics, Inc.
Decision Date1990-05-18
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HEMAGEN ENA [JO-I] KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-05-18 under 510(k) number K902139. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMAGEN ENA [JO-I] KIT?

HEMAGEN ENA [JO-I] KIT is a medical device that received FDA 510(k) clearance on 1990-05-18. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K902139.

When did HEMAGEN ENA [JO-I] KIT receive FDA 510(k) clearance?

HEMAGEN ENA [JO-I] KIT received FDA 510(k) clearance on 1990-05-18, under 510(k) number K902139.

Who is the listed applicant for HEMAGEN ENA [JO-I] KIT?

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

What is the FDA product code for HEMAGEN ENA [JO-I] KIT?

The FDA product code for HEMAGEN ENA [JO-I] KIT is DHN.

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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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