Fisher Diagnostics is one of 13015 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Fisher Diagnostics - FDA 510(k) Cleared Devices
Recent clearances: ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls, ARCHITECT STAT TROPONIN-1, ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
16
Total
16
Cleared
0
Denied
Fisher Diagnostics has 16 FDA 510(k) cleared medical devices. Based in Mchenry, US.
Historical record: 16 cleared submissions from 1983 to 2017. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Fisher Diagnostics Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Precision For Medicine as regulatory consultant.
FDA 510(k) Regulatory Record - Fisher Diagnostics
16 devices
Cleared
Jun 01, 2017
ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT...
Microbiology
90d
Cleared
Sep 13, 2007
ARCHITECT STAT TROPONIN-1
Chemistry
190d
Cleared
Jul 18, 2006
ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
Immunology
320d
Cleared
May 10, 2006
ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM...
Immunology
259d
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
Dec 09, 2002
FISHER DIAGNOSTICS THROMBOSCREEN 1000
Hematology
63d
Cleared
Feb 15, 2002
PACIFIC HEMOSTASIS REFERENCE EMULSION
Hematology
123d
Cleared
Sep 07, 2001
PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
Hematology
178d
Cleared
Apr 19, 1985
FISHER DIAGNOSTICS LATEST-CRP TEST KIT
Immunology
94d
Cleared
Mar 04, 1985
FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES
Chemistry
115d