Medical Device Manufacturer · US , Mchenry , IL

Hycel, Inc. - FDA 510(k) Cleared Devices

22 submissions · 21 cleared · Since 1976

22

Total

21

Cleared

0

Denied

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

6 devices

1-6 of 6

Cleared Jan 03, 1979

HYCEL COUNTER 333

Hematology · 16d

Cleared Jan 03, 1979

HYCEL COUNTER 222

Hematology · 16d

Cleared Jan 03, 1979

HYCEL COUNTER 211

Hematology · 16d

Cleared Jul 27, 1978

ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER

Hematology · 48d

Cleared Aug 10, 1977

PLATELET COUNTER & HEMATOCRIT ACCES.

Hematology · 19d

Cleared Jul 11, 1977

COUNTER 700 & HC-700 HEMO 0 REF.

Hematology · 21d