Uplink Test System
FDA 510(k) K020371 · OraSure Technologies, Inc.
510(k) numberK020371
Submission
- Device name
- Uplink Test System
- Applicant
- OraSure Technologies, Inc.
Bethlehem, PA, US - Received
- February 4, 2002
- Decision date
- April 3, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
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| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 05/10/2024SE |
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| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…DJG · Traditional | Shanghai Accurature Diagnostics Co., Ltd. | 02/23/2024SE |
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Questions and answers
When was Uplink Test System cleared by the FDA?
Uplink Test System (K020371) received a 510(k) decision of Substantially Equivalent on April 3, 2002, 58 days after the submission was received.
What is the product code of K020371?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.