Sysmex Reagents America Inc

FDA Filings

This page includes the latest FDA filings for Sysmex Reagents America Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006949423
FEI Number3006949423
NameSYSMEX REAGENTS AMERICA, INC.
Owner & OperatorSYSMEX CORPORATION
Contact Address1-5-1 WAKINOHAMA-KAIGANDORI CHUO-KU
KOBE JP-28 Hyogo 651-0073 JP
Official Correspondent
  • JAIME - HOUGHTON
  • 81-7826-50500-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressTwo Sysmex Way
Mundelein, IL 60060 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Sysmex Reagents America, Incorporated
2020-04-20
Sysmex Reagents America, Incorporated
Otc Medication2020-04-20
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
pocH-pack D2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
XW pack D2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
UF-CELLSHEATH2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
UF-CELLPACK SF2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
UF-CELLPACK CR2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
UF II Sheath2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
UF II PACK-BAC2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
UF II PACK SED2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
RETSEARCH II2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Cellsheath2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Cellsheath C2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Cellpack2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
CELLSHEATH CCS2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
CELLPACK S2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
CELLPACK DST2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
CELLPACK DFL2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
CELLPACK DCL2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
pocH-pack L2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
XW pack L2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Sulfolyser2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Stromatolyser-WH2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Stromatolyser-NR2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Stromatolyser-NR(L)2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Stromatolyser-IM2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Stromatolyser-FB2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Stromatolyser-4DS2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Stromatolyser-4DL2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Stromatolyser-3WP2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Quicklyser II2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Lysercell WPC2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Lysercell WNR2007-05-07
SYSMEX REAGENTS AMERICA, INC. [SYSMEX CORPORATION]
Lysercell WDF2007-05-07

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    U.S. Import Records [external site]
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    2020092971857Stadersand,Federal Republic of Germany -> Norfolk, VirginiaCHEMICALS - NO HAZARD GOODS URGENT MEDICAL SU PPLIES SODIUM CHLORIDE HS CODE 25010099 BA19 PCS
    2020091631334Shanghai ,China (Mainland) -> Tacoma, WashingtonPLASTIC BOTTLE AND PLASTIC CAP287 CTN
    2020082842031Osaka ,Japan -> Seattle, WashingtonETHYLENE GLYCOL PE BOTTLE NO.410 NATULAL COL OR PP CAP NO.411 COLORED EMAL O MATERIAL T260 PCS
    2020082746977Osaka ,Japan -> Seattle, WashingtonETHYLENE GLYCOL PE BOTTLE NO.410 NATULAL COL OR PP CAP NO.411 COLORED EMAL O MATERIAL T260 PCS
    2020072336325Shanghai ,China (Mainland) -> Seattle, WashingtonPLASTIC BOTTLE AND PLASTIC CAP416 CTN
    2020072128889Shanghai ,China (Mainland) -> Seattle, WashingtonPLASTIC BOTTLE AND PLASTIC CAP416 CTN
    2020072026861Shanghai ,China (Mainland) -> Seattle, WashingtonPLASTIC BOTTLE AND PLASTIC CAP416 CTN
    2020070335880Osaka ,Japan -> Seattle, WashingtonETHYLENE GLYCOL PE BOTTLE NO.410 NATULAL COL OR PP CAP NO.411 COLORED RHEODOL TW-0120V168 PCS
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