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FDA 510(k)

DIRECT ELISA FOR HERPES SIMPLEX VIRUS

K-Number: K853307 · 1985-12-23

ApplicantFairleigh Dickinson Laboratories, Inc.
Decision Date1985-12-23
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIRECT ELISA FOR HERPES SIMPLEX VIRUS is the device name listed in this FDA 510(k) record. The listed applicant is Fairleigh Dickinson Laboratories, Inc.. It received FDA 510(k) clearance on 1985-12-23 under 510(k) number K853307. The device is classified under product code GQN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECT ELISA FOR HERPES SIMPLEX VIRUS?

DIRECT ELISA FOR HERPES SIMPLEX VIRUS is a medical device that received FDA 510(k) clearance on 1985-12-23. The listed applicant is Fairleigh Dickinson Laboratories, Inc.. The 510(k) number is K853307.

When did DIRECT ELISA FOR HERPES SIMPLEX VIRUS receive FDA 510(k) clearance?

DIRECT ELISA FOR HERPES SIMPLEX VIRUS received FDA 510(k) clearance on 1985-12-23, under 510(k) number K853307.

Who is the listed applicant for DIRECT ELISA FOR HERPES SIMPLEX VIRUS?

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

What is the FDA product code for DIRECT ELISA FOR HERPES SIMPLEX VIRUS?

The FDA product code for DIRECT ELISA FOR HERPES SIMPLEX VIRUS is GQN.

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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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