Medical Device Manufacturer · US , Mchenry , IL

Omega Medical Electronics - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1982
21
Total
21
Cleared
0
Denied

Omega Medical Electronics has 21 FDA 510(k) cleared chemistry devices. Based in Mchenry, US.

Historical record: 21 cleared submissions from 1982 to 1983.

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 - Omega Medical Electronics

21 devices
1-21 of 21
Cleared Jan 07, 1983
PHOSPHORUS REAGENT SET
K823691 · CEO
Chemistry · 30d
Cleared Jul 22, 1982
GLUCOSE(ENZYMATIC) REAGENT SET
K821204 · CGA
Chemistry · 86d
Cleared Jul 22, 1982
SGPT-UV REAGENT SET
K821206 · CKA
Chemistry · 86d
Cleared Jul 22, 1982
UREA NITROGEN REAGENT SET
K821212 · CDW
Chemistry · 86d
Cleared Jul 20, 1982
LDH-UV REAGENT SET
K821201 · CFJ
Chemistry · 84d
Cleared Jul 20, 1982
TRIGLYCERIDE REAGENT SET
K821205 · CDT
Chemistry · 84d
Cleared Jul 20, 1982
SGOT-UV REAGENT SET
K821208 · CIT
Chemistry · 84d
Cleared Jul 14, 1982
SGPT REAGENT SET
K821207 · CKD
Chemistry · 78d
Cleared Jul 14, 1982
SGOT REAGENT SET
K821209 · CIQ
Chemistry · 78d
Cleared Jul 13, 1982
ALBUMIN REAGENT SET
K821193 · CIX
Chemistry · 77d
Cleared Jul 13, 1982
CHOLESTEROL REAGENT SET
K821195 · CHD
Chemistry · 77d
Cleared Jul 13, 1982
SERUM CALCIUM REAGENT SET
K821196 · CIC
Chemistry · 77d
Cleared Jul 13, 1982
TOTAL BILIRUBIN REAGENT SET
K821197 · CIG
Chemistry · 77d
Cleared Jul 13, 1982
DIRECT GLUCOSE REAGENT SET
K821198 · CGE
Chemistry · 77d
Cleared Jul 13, 1982
CREATININE REAGENT SET
K821199 · CGX
Chemistry · 77d
Cleared Jul 13, 1982
ALKALINE PHOSPHOTASE REAGENT SET
K821200 · CIO
Chemistry · 77d
Cleared Jul 13, 1982
HDL PRECIPITANT REAGENT SET
K821203 · LBR
Chemistry · 77d
Cleared Jul 13, 1982
SERUM TOTAL PROTEIN REAGENT SET
K821210 · CEK
Chemistry · 77d
Cleared Jul 13, 1982
URIC ACID REAGENT SET
K821213 · CDH
Chemistry · 77d
Cleared May 24, 1982
HEMOGLOBIN REAGENT SET
K821202 · GKK
Hematology · 27d
Cleared May 21, 1982
URIC ACID REAGENT SET(ENZYMATIC
K821214 · KNK
Chemistry · 24d
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