Medical Device Manufacturer · US , Mountain View , CA

Abbott Diagnostics - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1981

28

Total

28

Cleared

0

Denied

FDA 510(k) Regulatory Record - Abbott Diagnostics Hematology ✕

20 devices

1-12 of 20

Cleared Oct 18, 1996

ABBOTT CELL-DYN 4000 SYSTEM

Hematology · 186d

Cleared Apr 18, 1989

CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER

Hematology · 77d

Cleared Apr 21, 1988

CELL-DYN RAPID-LYSE AND HEMOGLOBLIN

Hematology · 36d

Cleared Mar 31, 1988

CELL-DYN ISOTONIC DILUENT

Hematology · 15d

Cleared Sep 09, 1987

CELL-DYN DIFF. SCREEN ISOTONIC DILUENT

Hematology · 20d

Cleared Sep 09, 1987

CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.

Hematology · 20d

Cleared Aug 06, 1987

CELL-DYN 610 HEMATOLOGY ANALYZER

Hematology · 24d

Cleared Mar 17, 1987

CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER

Hematology · 55d

Cleared Jan 01, 1986

CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER

Hematology · 64d

Cleared Sep 17, 1985

CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY

Hematology · 105d

Cleared Sep 03, 1985

CELL-DYN BRAND HEMATOLOGY REAGENTS

Hematology · 91d

Cleared Jul 05, 1985

AD150, AUTOMATED HEMATOLOGY DILUTOR

Hematology · 31d