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FDA 510(k)

HERPES SIMPLEX TYPE I

K-Number: K802939 · 1980-12-31

ApplicantOrion Diagnostica, Inc.
Decision Date1980-12-31
Product CodeGON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HERPES SIMPLEX TYPE I is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Inc.. It received FDA 510(k) clearance on 1980-12-31 under 510(k) number K802939. The device is classified under product code GON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERPES SIMPLEX TYPE I?

HERPES SIMPLEX TYPE I is a medical device that received FDA 510(k) clearance on 1980-12-31. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K802939.

When did HERPES SIMPLEX TYPE I receive FDA 510(k) clearance?

HERPES SIMPLEX TYPE I received FDA 510(k) clearance on 1980-12-31, under 510(k) number K802939.

Who is the listed applicant for HERPES SIMPLEX TYPE I?

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

What is the FDA product code for HERPES SIMPLEX TYPE I?

The FDA product code for HERPES SIMPLEX TYPE I is GON.

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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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