EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)— 510(k) K123050
Substantially EquivalentNantong Biotechnology Co., Ltd.
FDA 510(k) clearance K123050 for EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II), Substantially Equivalent on 2013-02-05. Applicant: Nantong Biotechnology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Nantong Biotechnology 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
- Gaithersburg, MD, US
Recent devices under product code LCX
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- K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.