FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST— 510(k) K061617
Substantially EquivalentTianjin New Bay Bioresearch Co., Ltd.
FDA 510(k) clearance K061617 for FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST, Substantially Equivalent on 2006-11-22. Applicant: Tianjin New Bay Bioresearch Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Tianjin New Bay Bioresearch Co., Ltd.
- Product code
- Code DKZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code DKZ
view allMore clearances from Tianjin New Bay Bioresearch Co., Ltd.
view all- K130275 — QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
- K122064 — FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE
- K112449 — QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
- K071489 — HOMECHECK MULTIPLE DRUG CUP TEST
- K073431 — FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T
Data sourced from openFDA. This site is unofficial and independent of the FDA.