Medical Device Manufacturer · CA , Quebec, Canada

Synermed, Inc. - FDA 510(k) Cleared Devices

45 submissions · 45 cleared · Since 1990

Recent clearances: SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT, SYNERMED TOTAL BILIRUBIN REAGENT KIT, SYNERMED IR 200 CHEMISTRY ANALYZER

45

Total

45

Cleared

0

Denied

FDA 510(k) Regulatory Record - Synermed, Inc. Chemistry ✕

45 devices

1-12 of 45

Cleared Sep 25, 1997

SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT

Chemistry · 37d

Cleared Aug 07, 1997

SYNERMED TOTAL BILIRUBIN REAGENT KIT

Chemistry · 17d

Cleared Jun 26, 1997

SYNERMED IR 200 CHEMISTRY ANALYZER

Chemistry · 63d

Cleared Mar 03, 1997

SYNERMED ISE REAGENTS

Chemistry · 250d

Cleared Dec 18, 1996

SYNERMED DIRECT BILIRUBIN REAGENT KIT

Chemistry · 78d

Cleared Mar 11, 1996

SYNERMED ENZYMATIC CO2 REAGENT KIT

Chemistry · 13d

Cleared Aug 31, 1995

SYNERMED CALCIUM REAGENT KIT

Chemistry · 44d

Cleared Jun 20, 1995

SYNERMED ISE REAGENTS

Chemistry · 42d

Cleared Sep 20, 1994

CREATININE-PO REAGENT KIT

Chemistry · 39d

Cleared May 03, 1994

SYNERMED AMYLASE REAGENT KIT

Chemistry · 56d

Cleared Apr 26, 1994

SYNERMED IR 500 CHEMISTRY ANALYZER

Chemistry · 151d

Cleared Apr 26, 1994

SYNERMED ISE REAGENTS

Chemistry · 35d

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