Emd Chemicals, Inc. - FDA 510(k) Cleared Devices
62
Total
62
Cleared
0
Denied
49 devices
Cleared
Sep 14, 1982
CHOLESTEROL STANDARD #65077
Chemistry
28d
Cleared
Sep 14, 1982
TOTAL PROTEIN STANDARD, #65074
Chemistry
28d
Cleared
Sep 14, 1982
PHOSPHOROUS STANDARD #65073
Chemistry
28d
Cleared
Sep 14, 1982
ALBUMIN STANDARD, #65070
Chemistry
28d
Cleared
Sep 14, 1982
BILIRUBIN CALIBRATOR #65071
Chemistry
28d
Cleared
Jun 25, 1982
ULTRACHEM E-GLU #64976&65040
Chemistry
38d
Cleared
Jun 03, 1982
ULTRACHEM CREA #64972
Chemistry
16d
Cleared
Jun 03, 1982
ULTRAZYME PLUS CKI, #64978,65027&65028
Chemistry
16d
Cleared
Jun 03, 1982
ULTRACHEM URIC ACID AIDH #65047
Chemistry
16d
Cleared
Jun 02, 1982
ULTRACHEM E-GLU, #64976 & 65040
Chemistry
15d
Cleared
Jun 02, 1982
ULTRACHEM GLUC-DH, #65048
Chemistry
15d
Cleared
Jun 02, 1982
CARDIOZYME PLUS CK-MB, #65045
Chemistry
15d
Cleared
Jun 02, 1982
ULTRACHEM URIC ACID AIDH, #65047
Chemistry
15d
Cleared
Jun 02, 1982
ULTRAZYME PLUS-GT, #64959 & 65032
Chemistry
15d
Cleared
Jun 02, 1982
ULTRACHEM GLUC-DH, #65048
Chemistry
15d
Cleared
Jun 02, 1982
ULTRACHEM E-GLU #64976 & 65040
Chemistry
15d
Cleared
Jun 02, 1982
ULTRAZYME PLUS ALP #64962,65029&65030
Chemistry
15d
Cleared
Jun 01, 1982
ENZYMATIC CHOLESTERAL OXIDASE #650550
Chemistry
19d
Cleared
Jun 01, 1982
ULTRAZYME PLUS CK-I, #64978,65027&65028
Chemistry
14d
Cleared
Jun 01, 1982
ULTRACHEM T-BILI, #64971
Chemistry
14d
Cleared
Jun 01, 1982
ULTRAZYME PLUS LDH, #64950,65038&65039
Chemistry
14d
Cleared
Jun 01, 1982
ULTRAZYME PLUS GOT, #64953,65033&65034
Chemistry
14d
Cleared
Jun 01, 1982
VERSACHEM ANALYZER
Chemistry
7d
Cleared
May 28, 1982
ULTRAZYME PLUS AMYL #65031&64982
Chemistry
10d