TPLC - Total Product Life Cycle

show TPLC since

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
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