Medical Device Manufacturer · US , Mchenry , IL

Fisher Diagnostics

16 submissions · 16 cleared · Since 1983
16
Total
16
Cleared
0
Denied

Fisher Diagnostics — FDA 510(k) Submissions

Fisher Diagnostics has submitted 16 FDA 510(k) premarket notifications since 1983, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Immunoassay Method, Troponin Subunit, System, Test, Thyroid Autoantibody, Agglutination Method, Human Chorionic Gonadotropin, Instrument, Coagulation, Automated, Fluorometric Method, Cpk Or Isoenzymes . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
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
K170652 · PRI Procalcitonin Assay · Microbiology
Jun 2017 90d
ARCHITECT STAT TROPONIN-1; MYOGLOBIN
K070640 · MMI Immunoassay Method,... · Chemistry
Sep 2007 190d
ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
K052407 · JZO System, Test, Thyroid... · Immunology
Jul 2006 320d
ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
K052308 · JZO System, Test, Thyroid... · Immunology
May 2006 259d
ARCHITECT STAT MYO IMMUNOASSAY
K042924 · DDR Myoglobin, Antigen,... · Chemistry
Jan 2005 94d
ARCHITECT STAT TROPONIN-I IMMUNOASSAY
K041192 · MMI Immunoassay Method,... · Chemistry
Aug 2004 98d
ARCHITECT STAT CK-MB IMMUNOASSAY
K041596 · JHX Fluorometric Method, Cpk... · Chemistry
Jul 2004 37d
FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN
K023362 · GKP Instrument, Coagulation,... · Hematology
Dec 2002 63d
PACIFIC HEMOSTASIS REFERENCE EMULSION
K013397 · JIX Calibrator, Multi-analyte... · Hematology
Feb 2002 123d
PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
K010750 · GGN Plasma, Coagulation Control · Hematology
Sep 2001 178d
FISHER DIAGNOSTICS LATEST-CRP TEST KIT
K850160 · DCK C-reactive Protein,... · Immunology
Apr 1985 94d
FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES
K844346 · JHJ Agglutination Method,... · Chemistry
Mar 1985 115d
FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT
K844347 · JHJ Agglutination Method,... · Chemistry
Jan 1985 75d
FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS
K844047 · JIT Calibrator, Secondary · Chemistry
Nov 1984 23d
THERACHEM TDC THERAPEUTIC DRUG CONTROL
K840921 · DIF Drug Mixture Control... · Toxicology
Apr 1984 34d
TOXI CHEM SERUM ALCOHOL CONTROL
K833514 · DKC Alcohol Control Materials · Toxicology
Dec 1983 58d
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