Hycel, Inc. - FDA 510(k) Cleared Devices
22
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hycel, Inc. Chemistry ✕
16 devices
Cleared
Oct 06, 1980
HYCEL TRIGYCERIDE II TEST
Chemistry
Cleared
Feb 27, 1979
HYCEL M
Chemistry
6d
Cleared
Jan 26, 1979
KETOSTEROID TEST, HYCEL-17
Chemistry
30d
Cleared
Jan 26, 1979
HYCEL LDH-INT TEST
Chemistry
29d
Cleared
Jul 27, 1978
HMA URIC ACID TEST
Chemistry
41d
Cleared
May 03, 1978
LELECTIVE KINETIC SYSTEM-60
Chemistry
42d
Cleared
Apr 05, 1978
DIRECT UREA NITROGEN TEST
Chemistry
47d
Cleared
Jan 30, 1978
17-HYDROXY TEST
Chemistry
34d
Cleared
Aug 22, 1977
ALBUMIN TEST, HMA ALBUMIN TEST
Chemistry
42d
Cleared
Aug 10, 1977
LDH-INT TEST
Chemistry
21d
Cleared
Jul 21, 1977
CPK-INT TEST
Chemistry
23d
Cleared
Jul 05, 1977
HEMOTOLOGY PRODU&TS (5 IN ALL)
Chemistry
64d