Medical Device Manufacturer · US , Chelsea , MI

Morax - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1996

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Morax Chemistry ✕

6 devices

1-6 of 6

Cleared Jan 17, 2002

MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123

Chemistry · 150d

Cleared Dec 29, 1999

HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT,...

Chemistry · 188d

Cleared Jun 18, 1999

HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT...

Chemistry · 143d

Cleared Oct 07, 1998

HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI...

Chemistry · 282d

Cleared Oct 27, 1997

HYDRAGEL 7,15,30, CHOL-HDL KIT

Chemistry · 150d

Cleared Jul 17, 1996

HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT

Chemistry · 197d