Medical Device Manufacturer · US , Mchenry , IL

Harleco Diagnostics - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1976
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Harleco Diagnostics Chemistry
23 devices
1-23 of 23
Cleared Nov 22, 1982
URIC ACID STANDARD, 8MG/DL #65078
K823147 · JIS
Chemistry · 28d
Cleared Oct 27, 1982
TRIGLYCERIDE CALIBRATOR
K822852 · JIT
Chemistry · 33d
Cleared Sep 02, 1982
ULTRACHEM BUN-UV, 65080 & 65081
K822323 · CDW
Chemistry · 30d
Cleared Jul 14, 1982
ULTRAZYME PLUS 2GT
K821871 · JPZ
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM URIC ACID AIDH
K821872 · CDO
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM T-BILI
K821873 · CIG
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS HBD
K821877 · JMK
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS LDH
K821878 · CFJ
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM T.P.
K821879 · CEX
Chemistry · 19d
Cleared Jul 14, 1982
ULTRA CHEM ALB
K821880 · CIX
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM CREA
K821881 · CGX
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS GPT
K821882 · CKA
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS CK-I
K821883 · CGS
Chemistry · 19d
Cleared Jul 13, 1982
ULTRAZYME PLUS AMYL
K821869 · JFJ
Chemistry · 18d
Cleared Jul 13, 1982
ULTRAZYME PLUS ALP
K821870 · CJE
Chemistry · 18d
Cleared Jul 13, 1982
ULTRACHEM PHOS
K821874 · CEO
Chemistry · 18d
Cleared Jul 13, 1982
ULTRACHEM TRI-ES
K821875 · CDT
Chemistry · 18d
Cleared Jul 13, 1982
ULTRAZYME PLUS GOT
K821876 · CIT
Chemistry · 18d
Cleared Jul 08, 1982
ULTRACHEM E-GLU
K821868 · CFR
Chemistry · 13d
Cleared Jul 06, 1982
ULTRACHEM GLUC-DH
K821867 · LFR
Chemistry · 11d
Cleared Jul 01, 1977
CPK ULTRAZYME PLUS
K770694 · CGS
Chemistry · 77d
Cleared Jun 17, 1977
LDH ULTRAZYME PLUS
K770613 · CFJ
Chemistry · 78d
Cleared Nov 30, 1976
AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL
K761026 · CIX
Chemistry · 18d
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