FDA Premarket Notification 510(k)s for Lyme Disease Tests from 1987 thru June 2001

Lyme disease is a serious bacterial infection caused by a tick bite and affects humans and animals.

"Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k)."

See more information about 510(k)s at:

Information on Releasable 510(k)s

FDA 95-4158, "Premarket Notification 510(k): Regulatory Requirements for Medical Devices".

The search links and data below were found at:

FDA Releasable Premarket Notification 510(K) Database Search

The table below is a compilation of line items from the following three search links:

FDA Premarket Notification 510(k)s Database Search Results for burgdorferi - 20 on 19 Jun 01

FDA Premarket Notification 510(k)s Database Search Results for Lyme%20 (i.e., Lyme followed by a space) - 39 of 41 on 19 Jun 01

FDA Premarket Notification 510(k)s Database Search Results for Lyme- (i.e., Lyme followed by a dash) - 2 of 2 on 19 Jun 01

FDA Premarket Notification 510(k)s for Lyme Disease Tests from 1987 thru June 2001

Last updated on 19 June 2001 by
Art Doherty
Lompoc, California
doherty@utech.net

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