ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C— 510(k) K071930
Substantially EquivalentBlue Cross Bio-Medical Co., Ltd.
FDA 510(k) clearance K071930 for ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C, Substantially Equivalent on 2007-12-18. Applicant: Blue Cross Bio-Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Blue Cross Bio-Medical Co., Ltd.
- Product code
- Product 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
- Beijing, CN
Recent devices under product code LCX
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Data sourced from openFDA. This site is unofficial and independent of the FDA.