Harleco Diagnostics - FDA 510(k) Cleared Devices
Recent clearances: URIC ACID STANDARD, 8MG/DL #65078, TRIGLYCERIDE CALIBRATOR, ULTRACHEM BUN-UV, 65080 & 65081
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Harleco Diagnostics Chemistry ✕
23 devices
Cleared
Nov 22, 1982
URIC ACID STANDARD, 8MG/DL #65078
Chemistry
28d
Cleared
Oct 27, 1982
TRIGLYCERIDE CALIBRATOR
Chemistry
33d
Cleared
Sep 02, 1982
ULTRACHEM BUN-UV, 65080 & 65081
Chemistry
30d
Cleared
Jul 14, 1982
ULTRAZYME PLUS 2GT
Chemistry
19d
Cleared
Jul 14, 1982
ULTRACHEM URIC ACID AIDH
Chemistry
19d
Cleared
Jul 14, 1982
ULTRACHEM T-BILI
Chemistry
19d
Cleared
Jul 14, 1982
ULTRAZYME PLUS HBD
Chemistry
19d
Cleared
Jul 14, 1982
ULTRAZYME PLUS LDH
Chemistry
19d
Cleared
Jul 14, 1982
ULTRACHEM T.P.
Chemistry
19d
Cleared
Jul 14, 1982
ULTRA CHEM ALB
Chemistry
19d
Cleared
Jul 14, 1982
ULTRACHEM CREA
Chemistry
19d
Cleared
Jul 14, 1982
ULTRAZYME PLUS GPT
Chemistry
19d