Harleco

FDA Filings

This page includes the latest FDA filings for Harleco. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
HARLECO
ULTRAZYME PLUS GAMMA GT(65055-65056)1982-02-12
HARLECO
ULTRACHEM GLUC-DH1981-12-31
HARLECO
ULTRACHEM ALB, ITEM #649701981-11-10
HARLECO
ULTRACHEM CREA ITEM #649721981-11-10
HARLECO
ULTRACHEM GLUC-DH SET, ITEM #650481981-11-10
HARLECO
ULTRAZYME-GT, ITEM #64959 & 650321981-11-10
HARLECO
ULTRACHEM CA, ITEM #649751981-11-10
HARLECO
ULTRACHEM E-CHOL, ITEM #650251981-11-10
HARLECO
ULTRACHEM TP, ITEM #649741981-11-10
HARLECO
ULTRA ZYME PLUS AMYL #64982 & 650311981-10-02
HARLECO
ULTRA ZYME PLUS CK-1 #64978, 65027 & 281981-10-02
HARLECO
ULTRA ZYME PLUS ALP #64962, 65029 & 301981-09-29
HARLECO
ULTRA CHEM E-GLU #64976 & 650401981-09-29
HARLECO
ULTRA ZYME PLUS GOT #64953, 65033 & 341981-09-24
HARLECO
ULTRA ZYME PLUS GPT, #64956, 65035 & 361981-09-24
HARLECO
ULTRA ZYME PLUS LDH #64950, 65038 & 391981-09-24
HARLECO
ULTRA CHEM E-TRIG #650241981-09-24
HARLECO
ULTRACHEM URIC ACID ALDH, ITEM #650471981-09-23
HARLECO
ACR ENZYMATIC GLUCOSE OXIDASE1981-08-31
HARLECO
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)1981-06-25
HARLECO
CARDIOZYME PLUS CK-MB ITEM #65045 (G)1981-06-25
HARLECO
CARDIOZYME PLUS CK-TOTAL ITEM #650461981-06-25
HARLECO
CARDIOZYME PLUS CK-MB ITEM #650451981-06-25
HARLECO
ULTRACHEM GLUC-DH, ITEM NO. 650481981-05-27
HARLECO
HEMOCOLOR STAIN SET1981-04-08
HARLECO
QUALITROL #650571981-03-31
HARLECO
CARDIOZYME PLUS CK-TOTAL #650461981-01-09
HARLECO
CARDIO ZYME PLUS CK-MB #650451981-01-09
HARLECO
SYSING AND HEMOGLOBIN REAGENT1978-06-22
HARLECO
ISOTONIC BUFFERED SALINE1978-06-14
HARLECO
ULTRACHEM T-BILI 64971 GILFORD 35001978-05-19
HARLECO
ULTRACHEM ENZYMATIC CHOLESTEROL 650251978-05-19
HARLECO
ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM1978-05-19
HARLECO
ULTRACHEM CREATININE 64972, CENTRIFUCHEM1978-05-19
HARLECO
TRIGLYCERIDE INSTRUMENT APPLICATION1978-03-09
HARLECO
ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI.1978-03-09
HARLECO
ULTRAZYME PLUS CK-11978-03-09
HARLECO
ULTRAZYME PLUS GT1978-03-09
HARLECO
ULTRAZYME PLUS LDH1978-02-14
HARLECO
ULTRAZYME PLUS HBD1978-02-13
HARLECO
ULTRAZYME PLUS GOT1978-02-13
HARLECO
ULTRAZYME PLUS GPT1978-02-13
HARLECO
ULTRAZYME PLUS ALP1978-02-13
HARLECO
IRON BINDING CAPACITY CHEMISTRY1978-02-13
HARLECO
GLUCOSE REAGENT FOR GLUCOSE ANALYZER1978-02-13
HARLECO
ULTRACHEM ALBUMIN1978-02-07
HARLECO
ULTRACHEM E-GLU, MANUAL DETERM.1978-02-01
HARLECO
CLINICARD CK-II1978-01-05
HARLECO
CREATININE, 649721977-12-06
HARLECO
ULTRACHEM PHOSPHORUS, 649731977-12-06
HARLECO
ULTRACHEM TOTAL PROTEIN, #649741977-12-06
HARLECO
CREATININE URINE APPLI.-#323081977-11-28
HARLECO
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL1977-11-17
HARLECO
GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-11977-11-17
HARLECO
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*1977-11-17
HARLECO
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP1977-11-17
HARLECO
GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT1977-11-15
HARLECO
GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH1977-11-15
HARLECO
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT1977-11-14
HARLECO
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT1977-11-14
HARLECO
CALCIUM SET, ITEM NO. 650041977-11-14
HARLECO
IRON SET, ITEM NO. 650081977-11-14
HARLECO
TOTAL PROTEIN SET, ITEM NO. 640101977-11-11
HARLECO
KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP1977-11-02
HARLECO
GLUCOSE REAGENT FOR GLUC. ANALYZER1977-10-18
HARLECO
HISTOCHEMICAL AFB DEMONSTRATION1977-08-22
HARLECO
UNIPAK TOTAL & DIRECT BILIRUBIN1977-07-21
HARLECO
UNIPAK TOTAL BILIRUBIN1977-07-21
HARLECO
ULTRACHEM CREATININE1977-07-11
HARLECO
AUTO-ENZYMATIC GLUCOSE1977-03-01
HARLECO
MANUEL BILIRUBIN REAGENT SET1977-01-31
HARLECO
AUTO-INORGANIC PHOSPHORUS REAGENT1976-12-29
HARLECO
AUTO TOTAL BILIRUBIN REAGENT1976-12-21
HARLECO
AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL1976-11-30
HARLECO
AUTO-ALBUMIN REAG FOR ABBOTT ABA-1001976-11-30
HARLECO
AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN1976-11-30
HARLECO
ULTRAZYME AMYLASE1976-09-21
HARLECO
ENZYMATIC TRIGLYCERIDE1976-09-15
HARLECO
CPK - ISOENZYMES1976-09-15

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