Medical Device Manufacturer · US , Mchenry , IL

Fisher Diagnostics - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1983

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fisher Diagnostics Chemistry ✕

7 devices

1-7 of 7

Cleared Sep 13, 2007

ARCHITECT STAT TROPONIN-1

Chemistry · 190d

Cleared Jan 24, 2005

ARCHITECT STAT MYO IMMUNOASSAY

Chemistry · 94d

Cleared Aug 12, 2004

ARCHITECT STAT TROPONIN-I IMMUNOASSAY

Chemistry · 98d

Cleared Jul 21, 2004

ARCHITECT STAT CK-MB IMMUNOASSAY

Chemistry · 37d

Cleared Mar 04, 1985

FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES

Chemistry · 115d

Cleared Jan 23, 1985

FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT

Chemistry · 75d

Cleared Nov 09, 1984

FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS

Chemistry · 23d