Redi-Screen

FDA 510(k) K000979 · Redwood Biotech, Inc.

Substantially Equivalent

510(k) numberK000979

Submission

Device name
Redi-Screen
Applicant
Redwood Biotech, Inc.
Sunnyvale, CA, US
Received
March 27, 2000
Decision date
April 10, 2000
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LAF – Gas Chromatography, Methamphetamine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3610
Specialty
Clinical Toxicology

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More from Lin-Zhi International, Inc.

510(k)DeviceDecision
K993100Redi-ScreenDJC · Special 10/06/1999SE
K991698Redi-Test PCPLCM · Traditional 08/25/1999SE
K991110Redi-Test CocaineDIO · Traditional 07/26/1999SE
K991504Redi-Test MethamphetamineLAF · Traditional 07/22/1999SE
K990870Redi-Test THCLDJ · Traditional 04/27/1999SE

Questions and answers

When was Redi-Screen cleared by the FDA?

Redi-Screen (K000979) received a 510(k) decision of Substantially Equivalent on April 10, 2000, 14 days after the submission was received.

What is the product code of K000979?

The FDA product code is LAF – Gas Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.