Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041 (5000 Tests Kit)
FDA 510(k) K020395 · Lin-Zhi International, Inc.
510(k) numberK020395
Submission
- Device name
- Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041 (5000 Tests Kit)
- Applicant
- Lin-Zhi International, Inc.
San Jose, CA, US - Received
- February 6, 2002
- Decision date
- June 4, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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Questions and answers
When was Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041 (5000 Tests Kit) cleared by the FDA?
Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041 (5000 Tests Kit) (K020395) received a 510(k) decision of Substantially Equivalent on June 4, 2002, 118 days after the submission was received.
What is the product code of K020395?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.