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

Harleco Diagnostics has 23 FDA 510(k) cleared chemistry devices. Based in Mchenry, US.

Historical record: 23 cleared submissions from 1976 to 1982.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Harleco Diagnostics
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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