Medical Device Manufacturer · US , Mchenry , IL

Coulter Electronics, Inc. - FDA 510(k) Cleared Devices

101 submissions · 101 cleared · Since 1976

101

Total

101

Cleared

0

Denied

FDA 510(k) Regulatory Record - Coulter Electronics, Inc. Hematology ✕

51 devices

1-12 of 51

Cleared Apr 25, 1994

CD8 CYTOSPHERES KIT

Hematology · 627d

Cleared Apr 05, 1993

COULTER RETIC-C CELL CONTROL

Hematology · 83d

Cleared Dec 29, 1992

CD4 CYTOSPHERES KIT

Hematology · 287d

Cleared Oct 14, 1992

COULTER MULTI-Q-PREP

Hematology · 90d

Cleared Aug 17, 1992

Hematology · 101d

Cleared Jul 27, 1992

COULTER MAXM W/ AUTOLOADER

Hematology · 52d

Cleared Jul 06, 1992

Hematology · 95d

Cleared Jul 17, 1991

PX COULTER(R) CELL CONTROL

Hematology · 64d

Cleared Jun 17, 1991

COULTER(R) MH010

Hematology · 81d

Cleared Feb 22, 1989

COULTER FLOW RETICULOCYTE REAGENT

Hematology · 56d

Cleared Feb 16, 1989

COULTER 5P CONTROL

Hematology · 73d

Cleared Dec 28, 1988

Hematology · 19d

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