Morax

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K033277HYDRAGEL CSF ISOFOCUSING KITSNovember 4, 2003
K012789MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123January 17, 2002
K992148HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KITDecember 29, 1999
K991362HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E)June 21, 1999
K990250HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LJune 18, 1999
K981048HYDRAGEL 6 CSF KITOctober 7, 1998
K974854HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207October 7, 1998
K972591HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KITMarch 4, 1998
K972015HYDRAGEL 7,15,30, CHOL-HDL KITOctober 27, 1997
K963844HYDRAGEL 15 HB A1C KITApril 22, 1997
K960029HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KITJuly 17, 1996
K960669HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITSJuly 12, 1996