Harleco Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K823147URIC ACID STANDARD, 8MG/DL #65078November 22, 1982
K822852TRIGLYCERIDE CALIBRATOROctober 27, 1982
K822323ULTRACHEM BUN-UV, 65080 & 65081September 2, 1982
K821877ULTRAZYME PLUS HBDJuly 14, 1982
K821883ULTRAZYME PLUS CK-IJuly 14, 1982
K821882ULTRAZYME PLUS GPTJuly 14, 1982
K821880ULTRA CHEM ALBJuly 14, 1982
K821879ULTRACHEM T.P.July 14, 1982
K821873ULTRACHEM T-BILIJuly 14, 1982
K821878ULTRAZYME PLUS LDHJuly 14, 1982
K821872ULTRACHEM URIC ACID AIDHJuly 14, 1982
K821871ULTRAZYME PLUS 2GTJuly 14, 1982
K821881ULTRACHEM CREAJuly 14, 1982
K821869ULTRAZYME PLUS AMYLJuly 13, 1982
K821870ULTRAZYME PLUS ALPJuly 13, 1982
K821876ULTRAZYME PLUS GOTJuly 13, 1982
K821875ULTRACHEM TRI-ESJuly 13, 1982
K821874ULTRACHEM PHOSJuly 13, 1982
K821868ULTRACHEM E-GLUJuly 8, 1982
K821867ULTRACHEM GLUC-DHJuly 6, 1982