QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST— 510(k) K112449
Substantially EquivalentTianjin New Bay Bioresearch Co., Ltd.
FDA 510(k) clearance K112449 for QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST, Substantially Equivalent on 2012-09-24. Applicant: Tianjin New Bay Bioresearch Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Tianjin New Bay Bioresearch Co., Ltd.
- Product code
- Code LCX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yorba Linda, CA, US
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- K073431 — FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T
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Data sourced from openFDA. This site is unofficial and independent of the FDA.