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FDA 510(k)

HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)

K-Number: K952077 · 1995-06-05

ApplicantHemagen Diagnostics, Inc.
Decision Date1995-06-05
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HEMAGEN ENA SCREEN-6 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 1995-06-05 under 510(k) number K952077. 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 SCREEN-6 KIT (EIA METHOD)?

HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) is a medical device that received FDA 510(k) clearance on 1995-06-05. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K952077.

When did HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) receive FDA 510(k) clearance?

HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) received FDA 510(k) clearance on 1995-06-05, under 510(k) number K952077.

Who is the listed applicant for HEMAGEN ENA SCREEN-6 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 SCREEN-6 KIT (EIA METHOD)?

The FDA product code for HEMAGEN ENA SCREEN-6 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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