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FDA 510(k)

VIRGO AMA ELISA KIT

K-Number: K971909 · 1997-06-20

ApplicantHemagen Diagnostics, Inc.
Decision Date1997-06-20
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VIRGO AMA ELISA 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 1997-06-20 under 510(k) number K971909. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRGO AMA ELISA KIT?

VIRGO AMA ELISA KIT is a medical device that received FDA 510(k) clearance on 1997-06-20. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K971909.

When did VIRGO AMA ELISA KIT receive FDA 510(k) clearance?

VIRGO AMA ELISA KIT received FDA 510(k) clearance on 1997-06-20, under 510(k) number K971909.

Who is the listed applicant for VIRGO AMA ELISA 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 VIRGO AMA ELISA KIT?

The FDA product code for VIRGO AMA ELISA KIT is DBM.

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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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