Redi-Test THC

FDA 510(k) K990870 · Redwood Biotech, Inc.

Substantially Equivalent

510(k) numberK990870

Submission

Device name
Redi-Test THC
Applicant
Redwood Biotech, Inc.
Sunnyvale, CA, US
Received
March 16, 1999
Decision date
April 27, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LDJ – Enzyme Immunoassay, Cannabinoids
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3870
Specialty
Clinical Toxicology

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More from Healgen Scientific,, LLC

510(k)DeviceDecision
K000979Redi-ScreenLAF · Special 04/10/2000SE
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

Questions and answers

When was Redi-Test THC cleared by the FDA?

Redi-Test THC (K990870) received a 510(k) decision of Substantially Equivalent on April 27, 1999, 42 days after the submission was received.

What is the product code of K990870?

The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.