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FDA 510(k)

HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)

K-Number: K915234 · 1991-12-20

ApplicantHemagen Diagnostics, Inc.
Decision Date1991-12-20
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) 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 1991-12-20 under 510(k) number K915234. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)?

HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) is a medical device that received FDA 510(k) clearance on 1991-12-20. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K915234.

When did HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) receive FDA 510(k) clearance?

HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) received FDA 510(k) clearance on 1991-12-20, under 510(k) number K915234.

Who is the listed applicant for HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)?

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 (SS-A/SS-B) KIT (EIA METHOD)?

The FDA product code for HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) is LLL.

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Related Devices (Code: LLL)

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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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