Harleco

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
116
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K820233ULTRAZYME PLUS GAMMA GT(65055-65056)February 12, 1982
K813427ULTRACHEM GLUC-DHDecember 31, 1981
K813040ULTRACHEM CA, ITEM #64975November 10, 1981
K813044ULTRACHEM ALB, ITEM #64970November 10, 1981
K813042ULTRACHEM GLUC-DH SET, ITEM #65048November 10, 1981
K813038ULTRACHEM TP, ITEM #64974November 10, 1981
K813041ULTRAZYME-GT, ITEM #64959 & 65032November 10, 1981
K813039ULTRACHEM E-CHOL, ITEM #65025November 10, 1981
K813043ULTRACHEM CREA ITEM #64972November 10, 1981
K812593ULTRA ZYME PLUS CK-1 #64978, 65027 & 28October 2, 1981
K812594ULTRA ZYME PLUS AMYL #64982 & 65031October 2, 1981
K812595ULTRA CHEM E-GLU #64976 & 65040September 29, 1981
K812596ULTRA ZYME PLUS ALP #64962, 65029 & 30September 29, 1981
K812592ULTRA ZYME PLUS GOT #64953, 65033 & 34September 24, 1981
K812589ULTRA CHEM E-TRIG #65024September 24, 1981
K812591ULTRA ZYME PLUS GPT, #64956, 65035 & 36September 24, 1981
K812590ULTRA ZYME PLUS LDH #64950, 65038 & 39September 24, 1981
K812500ULTRACHEM URIC ACID ALDH, ITEM #65047September 23, 1981
K812258ACR ENZYMATIC GLUCOSE OXIDASEAugust 31, 1981
K811575CARDIOZYME PLUS CK-MB ITEM #65045 (G)June 25, 1981