FOR SURE ONE STEP BUPRENORPHINE TEST STRIP— 510(k) K042990
Substantially EquivalentTianjin New Bay Bioresearch Co., Ltd.
FDA 510(k) clearance K042990 for FOR SURE ONE STEP BUPRENORPHINE TEST STRIP, Substantially Equivalent on 2005-05-10. 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
- Carlsbad, CA, US
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