Medical Device Manufacturer · US , Mchenry , IL

Ortho Instruments - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1978

Recent clearances: ORTHO SPECTRUM, ORTHO AUTOMATED CELL COUNTER, HEMAC LASER HEMATOLOGY SYSTEM

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ortho Instruments Hematology ✕

6 devices

1-6 of 6

Cleared Dec 31, 1980

ORTHO HEMATOLOGY CONTROL

Hematology · 26d

Cleared Dec 31, 1980

ORTHO HEMOTOLOGY CONTROL-NORMAL

Hematology · 26d

Cleared Dec 31, 1980

ORTHO HEMATOLOGY CONTROL ABNORMAL LOW

Hematology · 26d

Cleared Oct 10, 1980

Hematology · 38d

Cleared Sep 09, 1980

ORTHO AUTOMATED CELL COUNTER

Hematology · 64d

Cleared Sep 14, 1978

HEMAC LASER HEMATOLOGY SYSTEM

Hematology · 66d