| Proprietary Name: |
Best Choice +/- Preg Test; Best Choice Early Preg Test; CVS Visual Early Preg Test; Discount Drug +/- Preg Test; Equaline Visual Early Preg Test; Exchange Select +/- Preg Test; Fact Plus +/- Preg Test; Generic +/- Preg Test; Good Sense +/- Preg Test; Good Sense Visual Early Preg Test; Health Mart +/- Preg Test; HEB Bi-Ling Early Preg Test; Hy-Vee Visual Early Preg Test; Kroger +/- Preg Test; Loblaws +/- Preg Test; Loblaws Visual Early Preg Test; London Drug +/- Preg Test; Meijer +/- Preg Test; Meijer Visual Early Preg test; Pharmasave +/- Preg Test; Rite Aid +/- Preg Test; Rite Aid Early Pregnancy Bilingual Test; SDM +/- Preg Test; Shopko +/- Preg Test; Shopko Visual Early Preg Test; Shur Fine +/- Preg Test; Sunmark +/- Preg Test; Target +/- Preg Test; Target Visual Early Preg Test; Topcare Visual Early Preg Test; Walgreens Early Pregnancy Bilingual Test; Walgreens Visual Early Preg Test; Walmart Equate +/- Preg Test; Walmart Equate Visual Early Preg Test; Western Family +/- Preg Test; Western Family Visual Early Preg Test |
| Classification Name: |
KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER |
| Product Code: |
LCX |
| Device Class: |
2 |
| Regulation Number: |
862.1155 |
| Medical Specialty: |
Clinical Chemistry |
| Registered Establishment Name: |
Abbott Diagnostics (Shanghai) Co., Ltd.
|
| Registered Establishment Number: |
3005128563
|
| Premarket Submission Number: |
K042280 |
| Owner/Operator: |
Abbott |
| Owner/Operator Number: |
9006731
|
| Establishment Operations: |
Contract Manufacturer
|
