FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE— 510(k) K122064
Substantially EquivalentTianjin New Bay Bioresearch Co., Ltd.
FDA 510(k) clearance K122064 for FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE, Substantially Equivalent on 2013-05-07. Applicant: Tianjin New Bay Bioresearch Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Tianjin New Bay Bioresearch Co., Ltd.
- Product code
- Code DJG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.