Medical Device Manufacturer · US , Chelsea , MI

Morax - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1996

Recent clearances: HYDRAGEL CSF ISOFOCUSING KITS, MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123, HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT

View 12 510(k) Devices ↓

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Morax Hematology ✕

2 devices

1-2 of 2

Cleared Jun 21, 1999

HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15...

Hematology · 68d

Cleared Apr 22, 1997

HYDRAGEL 15 HB A1C KIT

Hematology · 209d