LIA Pregnancy Test
510(k) K171136
LIA Pregnancy Test is a Class II device made by Lia Diagnostics, cleared under FDA 510(k) K171136 on 20 Nov 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171136 | Date20 Nov 2017 | StatusActive |
Official records
- FDA 510(k) database K171136
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LCX
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter).
- ACON MIDSTREAM PREGNANCY TEST by Acon Laboratories, Inc.
- HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) by HEALGEN SCIENTIFIC LLC
- HCG MIDSTREAM PREGNANCY TEST by Mizuho USA, Inc.
- ABBOTT ADVISOR ONE-STEP PREGNANCY TEST by Abbott Laboratories
- HOMECLINIC ONE STEP PREGNANCY TEST by Vanguard Biomedical Corp.
- ADVANCED QUALITY PREGNANCY TEST by Bionike, Inc.
- ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST by Advanced Care Products
- PARAID HCG-M04 by NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
- CLEARBLUE EASY by Unipath, Ltd.
- FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST by Armkel, LLC