Medical Device Manufacturer · US , Mchenry , IL

Harleco - FDA 510(k) Cleared Devices

116 submissions · 116 cleared · Since 1976
116
Total
116
Cleared
0
Denied
116 devices
51-75 of 116
Cleared Dec 06, 1977
ULTRACHEM PHOSPHORUS, 64973
K772156 · CEO
Chemistry · 20d
Cleared Dec 06, 1977
CREATININE, 64972
K772157 · CGX
Chemistry · 20d
Cleared Nov 28, 1977
CREATININE URINE APPLI.-#32308
K772107 · CGX
Chemistry · 21d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP
K772032 · CJE
Chemistry · 21d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*
K772033 · JMK
Chemistry · 21d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1
K772034
Chemistry · 21d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL
K772035 · JFJ
Chemistry · 21d
Cleared Nov 15, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH
K772028 · CFJ
Chemistry · 19d
Cleared Nov 15, 1977
GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT
K772029 · CIT
Chemistry · 19d
Cleared Nov 14, 1977
IRON SET, ITEM NO. 65008
K771927 · JMO
Chemistry · 31d
Cleared Nov 14, 1977
CALCIUM SET, ITEM NO. 65004
K771928 · CJY
Chemistry · 31d
Cleared Nov 14, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT
K772030 · CKA
Chemistry · 18d
Cleared Nov 14, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT
K772031
Chemistry · 18d
Cleared Nov 11, 1977
TOTAL PROTEIN SET, ITEM NO. 64010
K771926 · CEK
Chemistry · 28d
Cleared Nov 02, 1977
KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP
K771925 · KES
Pathology · 19d
Cleared Oct 18, 1977
GLUCOSE REAGENT FOR GLUC. ANALYZER
K771754 · CGA
Chemistry · 32d
Cleared Oct 14, 1977
CLINICARD CREATININE CHEMISTRY
K771773 · CGX
Chemistry · 25d
Cleared Sep 02, 1977
AMYLASE ULTRAZYME PLUS
K771388 · JFJ
Chemistry · 37d
Cleared Sep 02, 1977
CK-1 ULTRAZYME PLUS
K771389 · CGS
Chemistry · 37d
Cleared Aug 22, 1977
HISTOCHEMICAL AFB DEMONSTRATION
K771390 · ICL
Pathology · 26d
Cleared Aug 22, 1977
HISTOCHEMICAL FERRIC IRON SET
K771524 · IAE
Hematology · 14d
Cleared Jul 21, 1977
UNIPAK BUN
K771087 · CDW
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK URIC ACID
K771088 · KNK
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK TOTAL BILIRUBIN
K771089 · CIG
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK GLUCOSE
K771091 · CGE
Chemistry · 35d

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