Benzodiazepine Enzyme Immunoassay

FDA 510(k) K032365 · Lin-Zhi International, Inc.

Substantially Equivalent

510(k) numberK032365

Submission

Device name
Benzodiazepine Enzyme Immunoassay
Applicant
Lin-Zhi International, Inc.
Synnyvale, CA, US
Received
July 31, 2003
Decision date
September 5, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JXM – Enzyme Immunoassay, Benzodiazepine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3170
Specialty
Clinical Toxicology

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Questions and answers

When was Benzodiazepine Enzyme Immunoassay cleared by the FDA?

Benzodiazepine Enzyme Immunoassay (K032365) received a 510(k) decision of Substantially Equivalent on September 5, 2003, 36 days after the submission was received.

What is the product code of K032365?

The FDA product code is JXM – Enzyme Immunoassay, Benzodiazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3170.