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Harleco

FDA 510(k) & PMA Approved Devices — 116 products

Total Devices116
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K820233 ULTRAZYME PLUS GAMMA GT(65055-65056)JQB1982-02-12 View
510(k) K813427 ULTRACHEM GLUC-DHLFR1981-12-31 View
510(k) K813039 ULTRACHEM E-CHOL, ITEM #65025CHH1981-11-10 View
510(k) K813042 ULTRACHEM GLUC-DH SET, ITEM #65048LFR1981-11-10 View
510(k) K813044 ULTRACHEM ALB, ITEM #64970CIX1981-11-10 View
510(k) K813043 ULTRACHEM CREA ITEM #64972CGX1981-11-10 View
510(k) K813038 ULTRACHEM TP, ITEM #64974CEK1981-11-10 View
510(k) K813040 ULTRACHEM CA, ITEM #64975CJY1981-11-10 View
510(k) K813041 ULTRAZYME-GT, ITEM #64959 & 65032JQB1981-11-10 View
510(k) K812593 ULTRA ZYME PLUS CK-1 #64978, 65027 & 28CGS1981-10-02 View
510(k) K812594 ULTRA ZYME PLUS AMYL #64982 & 65031CIJ1981-10-02 View
510(k) K812595 ULTRA CHEM E-GLU #64976 & 65040CFR1981-09-29 View
510(k) K812596 ULTRA ZYME PLUS ALP #64962, 65029 & 30CJE1981-09-29 View
510(k) K812589 ULTRA CHEM E-TRIG #65024CDT1981-09-24 View
510(k) K812590 ULTRA ZYME PLUS LDH #64950, 65038 & 39CFJ1981-09-24 View
510(k) K812591 ULTRA ZYME PLUS GPT, #64956, 65035 & 36CKA1981-09-24 View
510(k) K812592 ULTRA ZYME PLUS GOT #64953, 65033 & 34CIT1981-09-24 View
510(k) K812500 ULTRACHEM URIC ACID ALDH, ITEM #65047CDO1981-09-23 View
510(k) K812258 ACR ENZYMATIC GLUCOSE OXIDASECGA1981-08-31 View
510(k) K811574 CARDIOZYME PLUS CK-TOTAL ITEM #65046CGS1981-06-25 View
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