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Harleco

116 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ULTRAZYME PLUS GAMMA GT(65055-65056) (K820233)Harleco1982-02-12
ULTRACHEM GLUC-DH (K813427)Harleco1981-12-31
ULTRACHEM CA, ITEM #64975 (K813040)Harleco1981-11-10
ULTRACHEM ALB, ITEM #64970 (K813044)Harleco1981-11-10
ULTRACHEM E-CHOL, ITEM #65025 (K813039)Harleco1981-11-10
ULTRACHEM TP, ITEM #64974 (K813038)Harleco1981-11-10
ULTRACHEM CREA ITEM #64972 (K813043)Harleco1981-11-10
ULTRAZYME-GT, ITEM #64959 & 65032 (K813041)Harleco1981-11-10
ULTRACHEM GLUC-DH SET, ITEM #65048 (K813042)Harleco1981-11-10
ULTRA ZYME PLUS AMYL #64982 & 65031 (K812594)Harleco1981-10-02
ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 (K812593)Harleco1981-10-02
ULTRA CHEM E-GLU #64976 & 65040 (K812595)Harleco1981-09-29
ULTRA ZYME PLUS ALP #64962, 65029 & 30 (K812596)Harleco1981-09-29
ULTRA ZYME PLUS GOT #64953, 65033 & 34 (K812592)Harleco1981-09-24
ULTRA ZYME PLUS GPT, #64956, 65035 & 36 (K812591)Harleco1981-09-24
ULTRA ZYME PLUS LDH #64950, 65038 & 39 (K812590)Harleco1981-09-24
ULTRA CHEM E-TRIG #65024 (K812589)Harleco1981-09-24
ULTRACHEM URIC ACID ALDH, ITEM #65047 (K812500)Harleco1981-09-23
ACR ENZYMATIC GLUCOSE OXIDASE (K812258)Harleco1981-08-31
CARDIOZYME PLUS CK-MB ITEM #65045 (K811573)Harleco1981-06-25
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (K811574)Harleco1981-06-25
CARDIOZYME PLUS CK-MB ITEM #65045 (G) (K811575)Harleco1981-06-25
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) (K811576)Harleco1981-06-25
ULTRACHEM GLUC-DH, ITEM NO. 65048 (K811202)Harleco1981-05-27
HEMOCOLOR STAIN SET (K810684)Harleco1981-04-08
QUALITROL #65057 (K810725)Harleco1981-03-31
CARDIOZYME PLUS CK-TOTAL #65046 (K803169)Harleco1981-01-09
CARDIO ZYME PLUS CK-MB #65045 (K803168)Harleco1981-01-09
SYSING AND HEMOGLOBIN REAGENT (K780829)Harleco1978-06-22
ISOTONIC BUFFERED SALINE (K780830)Harleco1978-06-14
ULTRACHEM ENZYMATIC CHOLESTEROL 65025 (K780523)Harleco1978-05-19
ULTRACHEM T-BILI 64971 GILFORD 3500 (K780524)Harleco1978-05-19
ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM (K780515)Harleco1978-05-19
ULTRA ZYME PLUS AMYL 64982, GILFORD 3500 (K780513)Harleco1978-05-19
ULTRACHEM CREATININE 64972, CENTRIFUCHEM (K780514)Harleco1978-05-19
ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI. (K780141)Harleco1978-03-09
ULTRAZYME PLUS GT (K780099)Harleco1978-03-09
TRIGLYCERIDE INSTRUMENT APPLICATION (K780172)Harleco1978-03-09
ULTRAZYME PLUS CK-1 (K780100)Harleco1978-03-09
ULTRAZYME PLUS LDH (K780101)Harleco1978-02-14
ULTRAZYME PLUS GOT (K780103)Harleco1978-02-13
ULTRAZYME PLUS HBD (K780104)Harleco1978-02-13
ULTRAZYME PLUS GPT (K780102)Harleco1978-02-13
ULTRAZYME PLUS ALP (K780095)Harleco1978-02-13
IRON BINDING CAPACITY CHEMISTRY (K780094)Harleco1978-02-13
GLUCOSE REAGENT FOR GLUCOSE ANALYZER (K780093)Harleco1978-02-13
ULTRACHEM ALBUMIN (K780092)Harleco1978-02-07
ULTRACHEM E-GLU, MANUAL DETERM. (K780065)Harleco1978-02-01
CLINICARD CK-II (K772258)Harleco1978-01-05
ULTRACHEM PHOSPHORUS, 64973 (K772156)Harleco1977-12-06
ULTRACHEM TOTAL PROTEIN, #64974 (K772155)Harleco1977-12-06
CREATININE, 64972 (K772157)Harleco1977-12-06
CREATININE URINE APPLI.-#32308 (K772107)Harleco1977-11-28
GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1 (K772034)Harleco1977-11-17
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP (K772032)Harleco1977-11-17
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL (K772035)Harleco1977-11-17
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* (K772033)Harleco1977-11-17
GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT (K772029)Harleco1977-11-15
GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH (K772028)Harleco1977-11-15
IRON SET, ITEM NO. 65008 (K771927)Harleco1977-11-14
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT (K772031)Harleco1977-11-14
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT (K772030)Harleco1977-11-14
CALCIUM SET, ITEM NO. 65004 (K771928)Harleco1977-11-14
TOTAL PROTEIN SET, ITEM NO. 64010 (K771926)Harleco1977-11-11
KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP (K771925)Harleco1977-11-02
GLUCOSE REAGENT FOR GLUC. ANALYZER (K771754)Harleco1977-10-18
CLINICARD CREATININE CHEMISTRY (K771773)Harleco1977-10-14
AMYLASE ULTRAZYME PLUS (K771388)Harleco1977-09-02
CK-1 ULTRAZYME PLUS (K771389)Harleco1977-09-02
HISTOCHEMICAL FERRIC IRON SET (K771524)Harleco1977-08-22
HISTOCHEMICAL AFB DEMONSTRATION (K771390)Harleco1977-08-22
UNIPAK URIC ACID (K771088)Harleco1977-07-21
UNIPAK CHOLESTEROL (K771093)Harleco1977-07-21
CLINICARD UV AMYLASE CHEMISTRY (K771131)Harleco1977-07-21
UNIPAK BUN (K771087)Harleco1977-07-21
UNIPAK GLUCOSE (K771091)Harleco1977-07-21
UNIPAK TOTAL & DIRECT BILIRUBIN (K771092)Harleco1977-07-21
UNIPAK ALBUMIN (K771094)Harleco1977-07-21
UNIPAK TOTAL BILIRUBIN (K771089)Harleco1977-07-21
AUTO TOTAL PROTEIN FOR ANALYZER (K770887)Harleco1977-07-14
ULTRAZYME PLUS GOT (K770883)Harleco1977-07-14
ULTRAZYME PLUS HBD (K770871)Harleco1977-07-14
ULTRAZYME PLUS GPT (K770882)Harleco1977-07-14
AUTO-ENZYMATIC GLUCOSE FOR ANALYZER (K770886)Harleco1977-07-14
ULTRAZYME PLUS ALP (K770870)Harleco1977-07-14
ULTRACHEM CALCIUM (K770817)Harleco1977-07-11
ULTRAZYME PLUS GT (K770815)Harleco1977-07-11
ULTRACHEM ALBUMIN (K770816)Harleco1977-07-11
UNIPAK HEMOGLOBIN (K771090)Harleco1977-07-11
ULTRACHEM CREATININE (K770819)Harleco1977-07-11
ULTRAZYME PLUS, LDH (K770818)Harleco1977-07-11
ULTRACHEM INORGANIC PHOSPHORUS (K770820)Harleco1977-07-11
AUTO-ENZYMATIC GLUCOSE (K770229)Harleco1977-03-01
AUTO CREATININE REAGENT (GILFORD 3400-E) (K761280)Harleco1977-02-14
AUTO CREATININE REAGENT (ABBOTT SYSTEM) (K761279)Harleco1977-02-11
MANUEL BILIRUBIN REAGENT SET (K770121)Harleco1977-01-31
AUTO-INORGANIC PHOSPHORUS REAGENT (K761238)Harleco1976-12-29
AUTO-INORGANIC PHOSPHORUS REAGENT (K761239)Harleco1976-12-29
AUTO-ENZYMATIC GLUCOSE (K761240)Harleco1976-12-29
AUTO TOTAL BILIRUBIN REAGENT (K761218)Harleco1976-12-21
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