Hemocue Ab

FDA Filings

This page includes the latest FDA filings for Hemocue Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003044483
FEI Number3003044483
NameMatt Ackerman
Owner & OperatorHemoCue AB
Contact AddressKuvettgatan 1
Angelholm SE-M Skane lan [SE-12] 26271 SE
Official Correspondent
  • Rikard Almaker
  • 46-431-481-389
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address250S Kraemer Boulevard
Brea, CA 92821 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Hemocue AB
 HemoCue® Hb 301 Microcuvettes 1118142022-11-07
Hemocue AB
 HemoCue® Hb 301 Microcuvettes 1118122022-09-07
Hemocue AB
 HemoCue® Hb301 Analyzer 1218272020-09-14
Hemocue AB
 HemoCue® Hb 301 Microcuvettes 1118092020-09-14
HemoCue AB
HemoCue Hb 301 System2020-08-04
Hemocue AB
 HemoCue® 801 Connect 1391682019-07-02
Hemocue AB
 HemoCue® Urine Albumin Microcuvettes 1106082019-05-03
Hemocue AB
 HemoCue® Albumin 201 Analyzer 1206232019-05-03
Matt Ackerman [HemoCue AB]
HemoCue 801 Connect2019-04-23
Hemocue AB
 HemoCue® Hb 801 Microcuvettes 1119022019-03-11
Hemocue AB
 HemoCue® Hb 801 Analyzer 1219202019-03-11
Matt Ackerman [HemoCue AB]
HemoCue Hb 801 System2019-02-04
HemoCue AB
HemoCue Hb 801 System2019-02-01
Hemocue AB
 HemoCue® Hb301 Analyzer 121804US2018-07-06
Hemocue AB
 HemoCue® WBC Analyzer 1230012018-07-06
Hemocue AB
 HemoCue® Hb 201+ Analyzer 1217212018-07-06
Hemocue AB
 HemoCue® Hb 201+ Analyzer 1217202018-07-06
Hemocue AB
 HemoCue® Glucose 201 DM Analyzer 1214442018-07-06
Hemocue AB
 HemoCue® Glucose 201 DM Analyzer 1214222018-07-06
Hemocue AB
 HemoCue® Hb 201 DM Analyzer 1211462018-07-06
Hemocue AB
 HemoCue® Hb 201 DM Analyzer 1211352018-07-06
Hemocue AB
 HemoCue® Glucose 201 Analyzer 1207072018-07-06
Hemocue AB
 HemoCue® Glucose 201 Analyzer 1207062018-07-06
Hemocue AB
 HemoCue® Plasma/Low Hb Photometer 1203142018-07-06
Hemocue AB
 HemoCue® Hb 301 Microcuvettes 1118072018-07-06
Hemocue AB
 HemoCue® Hb 301 Microcuvettes 1118012018-07-06
Hemocue AB
 HemoCue® Hb 201 Microcuvettes 1117322018-07-06
Hemocue AB
 HemoCue® Hb 201 Microcuvettes 1117312018-07-06
Hemocue AB
 HemoCue® Hb 201 Microcuvettes 1117162018-07-06
Hemocue AB
 HemoCue® Hb 201 Microcuvettes 1117152018-07-06
Hemocue AB
 HemoCue® Glucose 201 Microcuvettes 1107232018-07-06
Hemocue AB
 HemoCue® Glucose 201 Microcuvettes 1107062018-07-06
Hemocue AB
 HemoCue® Glucose 201 Microcuvettes 1107052018-07-06
Hemocue AB
 HemoCue® Plasma/Low Hb Microcuvettes 1103022018-07-06
Hemocue AB
 HemoCue® WBC Microcuvettes 1130032018-03-29
Matt Ackerman [HemoCue AB]
HemoCue WBC System2007-11-09
Matt Ackerman [HemoCue AB]
HemoCue Hb 301 System2007-11-09
Matt Ackerman [HemoCue AB]
HemoCue Hb 201 DM System2007-11-09
Matt Ackerman [HemoCue AB]
HemoCue Glucose 201 DM System2007-11-09
Matt Ackerman [HemoCue AB]
HemoCue Hb 201 System2007-11-09
Matt Ackerman [HemoCue AB]
HemoCue Glucose 201 System2007-11-09
Matt Ackerman [HemoCue AB]
HemoCue Hb 301 System2007-11-09
Matt Ackerman [HemoCue AB]
HemoCue Plasma/Low System2007-11-09
HEMOCUE AB
HEMOCUE WBC SYSTEM2007-10-25
HemoCue AB
Automated Hemoglobin System2006-10-05
HEMOCUE AB
HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 1107122006-09-06
HEMOCUE AB
HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 1118012006-06-08
Matt Ackerman [HemoCue AB]
HEMOCUE URINE ALBUMIN MICROCUVETTE2006-03-13
Matt Ackerman [HemoCue AB]
HEMOCUE URINE ALBUMIN MICROCUVETTE2006-03-13
HEMOCUE AB
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM2006-02-17

Related Finance Registrations
NCAGE CodeA716NHEMOCUE AB
NCAGE CodeS7405HEMOCUE AB
CAGE CodeS7405HEMOCUE AB
CAGE CodeA716NHEMOCUE AB
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020090555159Reykjavik,Iceland -> Portland, Maine1X40RH FCL/LCL CONT SLAC 13 CLI MEDICAL TEST EQUIPMENT REF. 2333076 SET TEMP PLUS 5 DEG C13 PCS
2020072456561Reykjavik,Iceland -> Portland, Maine1X40RH FCL/FCL CONT SLAC 15 CLI MEDICAL EQUIPMENT REF. 2332277 SET TEMP PLUS 5 DEGREE C15 PCS
2020050840821Reykjavik,Iceland -> Portland, Maine1 X 40RH FCL/FCL CONT SLAC 25 PACKAGES MEDICAL TEST EQUIPMENT REF. 1272772/1272642 TEMP: +5,0 DEGR CELSIUS25 PCS
2020042547234Reykjavik,Iceland -> Portland, Maine1 X 40RH FCL/FCL CONT SLAC 25 PACKAGES MEDICAL TEST EQUIPMENT REF. 1272537/2330744 TEMP: +5,0 DEGR CELSIUS25 PCS
2020041359412Reykjavik,Iceland -> Portland, Maine1X40RH FCL/LCL CONT SLAC 1 LOT MEDICAL TEST EQUIPMENT REF. 2330463,474,46225 PCS
2020040862436Reykjavik,Iceland -> Portland, Maine1X40RH FCL/FCL CONT SLAC 1 LOT MEDICAL TEST EQUIPMENTS REF. 2330255-5726 PCS
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