Harleco
FDA 510(k) medical device clearances.
Top product codes for Harleco
Recent clearances by Harleco
1–100 of 116- K820233 — ULTRAZYME PLUS GAMMA GT(65055-65056)
- K813427 — ULTRACHEM GLUC-DH
- K813038 — ULTRACHEM TP, ITEM #64974
- K813039 — ULTRACHEM E-CHOL, ITEM #65025
- K813040 — ULTRACHEM CA, ITEM #64975
- K813041 — ULTRAZYME-GT, ITEM #64959 & 65032
- K813042 — ULTRACHEM GLUC-DH SET, ITEM #65048
- K813043 — ULTRACHEM CREA ITEM #64972
- K813044 — ULTRACHEM ALB, ITEM #64970
- K812593 — ULTRA ZYME PLUS CK-1 #64978, 65027 & 28
- K812594 — ULTRA ZYME PLUS AMYL #64982 & 65031
- K812595 — ULTRA CHEM E-GLU #64976 & 65040
- K812596 — ULTRA ZYME PLUS ALP #64962, 65029 & 30
- K812589 — ULTRA CHEM E-TRIG #65024
- K812590 — ULTRA ZYME PLUS LDH #64950, 65038 & 39
- K812591 — ULTRA ZYME PLUS GPT, #64956, 65035 & 36
- K812592 — ULTRA ZYME PLUS GOT #64953, 65033 & 34
- K812500 — ULTRACHEM URIC ACID ALDH, ITEM #65047
- K812258 — ACR ENZYMATIC GLUCOSE OXIDASE
- K811573 — CARDIOZYME PLUS CK-MB ITEM #65045
- K811574 — CARDIOZYME PLUS CK-TOTAL ITEM #65046
- K811575 — CARDIOZYME PLUS CK-MB ITEM #65045 (G)
- K811576 — CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)
- K811202 — ULTRACHEM GLUC-DH, ITEM NO. 65048
- K810684 — HEMOCOLOR STAIN SET
- K810725 — QUALITROL #65057
- K803168 — CARDIO ZYME PLUS CK-MB #65045
- K803169 — CARDIOZYME PLUS CK-TOTAL #65046
- K780829 — SYSING AND HEMOGLOBIN REAGENT
- K780830 — ISOTONIC BUFFERED SALINE
- K780513 — ULTRA ZYME PLUS AMYL 64982, GILFORD 3500
- K780514 — ULTRACHEM CREATININE 64972, CENTRIFUCHEM
- K780515 — ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM
- K780523 — ULTRACHEM ENZYMATIC CHOLESTEROL 65025
- K780524 — ULTRACHEM T-BILI 64971 GILFORD 3500
- K780099 — ULTRAZYME PLUS GT
- K780100 — ULTRAZYME PLUS CK-1
- K780141 — ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI.
- K780172 — TRIGLYCERIDE INSTRUMENT APPLICATION
- K780101 — ULTRAZYME PLUS LDH
- K780093 — GLUCOSE REAGENT FOR GLUCOSE ANALYZER
- K780094 — IRON BINDING CAPACITY CHEMISTRY
- K780095 — ULTRAZYME PLUS ALP
- K780102 — ULTRAZYME PLUS GPT
- K780103 — ULTRAZYME PLUS GOT
- K780104 — ULTRAZYME PLUS HBD
- K780092 — ULTRACHEM ALBUMIN
- K780065 — ULTRACHEM E-GLU, MANUAL DETERM.
- K772258 — CLINICARD CK-II
- K772155 — ULTRACHEM TOTAL PROTEIN, #64974
- K772156 — ULTRACHEM PHOSPHORUS, 64973
- K772157 — CREATININE, 64972
- K772107 — CREATININE URINE APPLI.-#32308
- K772032 — GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP
- K772033 — GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*
- K772034 — GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1
- K772035 — GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL
- K772028 — GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH
- K772029 — GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT
- K771927 — IRON SET, ITEM NO. 65008
- K771928 — CALCIUM SET, ITEM NO. 65004
- K772030 — GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT
- K772031 — GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT
- K771926 — TOTAL PROTEIN SET, ITEM NO. 64010
- K771925 — KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP
- K771754 — GLUCOSE REAGENT FOR GLUC. ANALYZER
- K771773 — CLINICARD CREATININE CHEMISTRY
- K771388 — AMYLASE ULTRAZYME PLUS
- K771389 — CK-1 ULTRAZYME PLUS
- K771390 — HISTOCHEMICAL AFB DEMONSTRATION
- K771524 — HISTOCHEMICAL FERRIC IRON SET
- K771087 — UNIPAK BUN
- K771088 — UNIPAK URIC ACID
- K771089 — UNIPAK TOTAL BILIRUBIN
- K771091 — UNIPAK GLUCOSE
- K771092 — UNIPAK TOTAL & DIRECT BILIRUBIN
- K771093 — UNIPAK CHOLESTEROL
- K771094 — UNIPAK ALBUMIN
- K771131 — CLINICARD UV AMYLASE CHEMISTRY
- K770870 — ULTRAZYME PLUS ALP
- K770871 — ULTRAZYME PLUS HBD
- K770882 — ULTRAZYME PLUS GPT
- K770883 — ULTRAZYME PLUS GOT
- K770886 — AUTO-ENZYMATIC GLUCOSE FOR ANALYZER
- K770887 — AUTO TOTAL PROTEIN FOR ANALYZER
- K770815 — ULTRAZYME PLUS GT
- K770816 — ULTRACHEM ALBUMIN
- K770817 — ULTRACHEM CALCIUM
- K770818 — ULTRAZYME PLUS, LDH
- K770819 — ULTRACHEM CREATININE
- K770820 — ULTRACHEM INORGANIC PHOSPHORUS
- K771090 — UNIPAK HEMOGLOBIN
- K770229 — AUTO-ENZYMATIC GLUCOSE
- K761280 — AUTO CREATININE REAGENT (GILFORD 3400-E)
- K761279 — AUTO CREATININE REAGENT (ABBOTT SYSTEM)
- K770121 — MANUEL BILIRUBIN REAGENT SET
- K761238 — AUTO-INORGANIC PHOSPHORUS REAGENT
- K761239 — AUTO-INORGANIC PHOSPHORUS REAGENT
- K761240 — AUTO-ENZYMATIC GLUCOSE
- K761217 — AUTO TOTAL PROTEIN
Data sourced from openFDA. This site is unofficial and independent of the FDA.