|
Device |
labware, assisted reproduction |
Product Code | MQK |
Regulation Number |
884.6160
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ALLWIN MEDICAL DEVICES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AUXOGYN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BONRAYBIO CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CRYO BIO SYSTEM |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CYTOSWIM LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DXNOW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HERTART |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
1. K123641 CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROP ...
|
2. K150756 Micro well group culture dish, 9-well; Micro well ...
|
HERTART APS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KITAZATO BIOPHARMA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KITAZATO BIOPHARMA CO;LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KITAZATO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LOTUS BIO LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MENICON CO., LTD. NEW BUSINESS DIVISION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MID-ATLANTIC DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NIDACON INTERNATIONAL AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORIGIO A/S |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
REPROBITECH CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
REPROLIFE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESEARCH INSTRUMENTS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THERMO FISHER SCIENTIFIC (NALGE NUNC INTL) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITROLIFE A/S |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VITROLIFE SWEDEN AB |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
|
|
|
|