Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron Systems
FDA 510(k) K081008 · Lin-Zhi International, Inc.
510(k) numberK081008
Submission
- Device name
- Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron Systems
- Applicant
- Lin-Zhi International, Inc.
Synnyvale, CA, US - Received
- April 10, 2008
- Decision date
- December 22, 2008
- 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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| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 01/16/2026SE |
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More from Shanghai Accurature Diagnostics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | 01/16/2026SE |
| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | 06/18/2025SE |
| K202007 | LZI Oxycodone III Enzyme ImmunoassayDJG · Traditional | 09/17/2020SE |
| K201938 | LZI Fentanyl II Enzyme ImmunoassayDJG · Traditional | 08/07/2020SE |
| K201223 | LZI Tramadol Enzyme ImmunoassayDJG · Traditional | 06/04/2020SE |
| K192299 | LZI Cotinine II Enzyme ImmunoassayMKU · Traditional | 11/21/2019SE |
| K192433 | LZI Methadone II Enzyme ImmunoassayDJR · Traditional | 10/04/2019SE |
| K181159 | LZI Fentanyl Enzyme ImmunoassayDJG · Traditional | 12/03/2018SE |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…DJR · Traditional | 06/26/2017SE |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…LDJ · Traditional | 05/28/2015SE |
Questions and answers
When was Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron Systems cleared by the FDA?
Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron Systems (K081008) received a 510(k) decision of Substantially Equivalent on December 22, 2008, 256 days after the submission was received.
What is the product code of K081008?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.