RAPID ONE STEP BUPRENORPHINE TEST CARD— 510(k) K042988
Substantially EquivalentTianjin New Bay Bioresearch Co., Ltd.
FDA 510(k) clearance K042988 for RAPID ONE STEP BUPRENORPHINE TEST CARD, Substantially Equivalent on 2005-05-12. 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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