ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD— 510(k) K140748
Substantially EquivalentCo-Innovation Biotech Co., Ltd.
FDA 510(k) clearance K140748 for ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD, Substantially Equivalent on 2014-08-20. Applicant: Co-Innovation Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Co-Innovation Biotech 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
- Guangzhou, Guangdong, CN
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