Proprietary Name: |
Clearblue Digital and Visual Pregnancy Kit; Clearblue Pregnancy Planning Kit; Clearblue Visual 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: |
K110433 |
Owner/Operator: |
Abbott Rapid Diagnostics Inc |
Owner/Operator Number: |
9006731
|
Establishment Operations: |
Contract Manufacturer
|