Emd Chemicals, Inc. - FDA 510(k) Cleared Devices
62
Total
62
Cleared
0
Denied
62 devices
Cleared
Feb 18, 1983
ULTRAZYME PLUS GAMMA GT-MCA #65055-65056
Chemistry
24d
Cleared
Jan 28, 1983
ULTRAZYME PLUS GAMMA-GT, #64959/65032
Chemistry
32d
Cleared
Jan 09, 1983
BUN-UN CENTRIFICHUM 500, #65080/81
Chemistry
65d
Cleared
Dec 28, 1982
ULTRA CHEM BAN-UV #65080 & 65081
Chemistry
36d
Cleared
Dec 26, 1982
ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080&
Chemistry
41d
Cleared
Dec 22, 1982
ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE
Chemistry
47d
Cleared
Nov 05, 1982
GLUCOSE/UREA NITROGEN STANDARD
Chemistry
32d
Cleared
Oct 27, 1982
MIDAS 1000 WRIGHT STAIN #66010
Hematology
19d
Cleared
Oct 27, 1982
MIDAS 1000 WRIGHT GIEMSA STAIN #66020
Hematology
19d
Cleared
Oct 27, 1982
MIDAS 100 HEMACOLOR STAIN #66030
Hematology
19d
Cleared
Sep 17, 1982
CALCIUM STANDARD, ITEM #65075
Chemistry
31d
Cleared
Sep 17, 1982
CREATININE STANDARD #65072
Chemistry
31d
Cleared
Sep 14, 1982
ULTRACHEM ENZYMATIC CHOL. OXIDASE
Chemistry
34d
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