CR3 Keyless Split Sample Cup Amphetamine-Cocaine
FDA 510(k) K141532 · Guangzhou Wondfo Biotech Co., Ltd.
510(k) numberK141532
Submission
- Device name
- CR3 Keyless Split Sample Cup Amphetamine-Cocaine
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
Gaithersburg, MD, US - Received
- June 10, 2014
- Decision date
- July 14, 2014
- 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 CR3 Keyless Split Sample Cup Amphetamine-Cocaine cleared by the FDA?
CR3 Keyless Split Sample Cup Amphetamine-Cocaine (K141532) received a 510(k) decision of Substantially Equivalent on July 14, 2014, 34 days after the submission was received.
What is the product code of K141532?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.