|
Device |
kit, test, pregnancy, hcg, over the counter |
Product Code | LCX |
Regulation Number |
862.1155
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACESO LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACON LABORATORIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACON LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASSURE TECH (HANGZHOU) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ATLAS LINK TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CO-INNOVATION BIOTECH CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU DECHENG BIOTECHNOLOGY CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU ALLTEST BIOTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU CLONGENE BIOTECH CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALSTONE BIOTECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANTONG EGENS BIOTECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QINGDAO HIGHTOP BIOTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RUNBIO BIOTECH CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAFECARE BIOTECH (HANGZHOU) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPD SWISS PRECISION DIAGNOSTICS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TRUE DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WHOLEPOWER BIOTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|