Medical Device Manufacturer · US , Fairfield , NJ

Schiapparelli Biosystems, Inc.

24 submissions · 24 cleared · Since 1993
24
Total
24
Cleared
0
Denied

Schiapparelli Biosystems, Inc. — FDA 510(k) Submissions

Schiapparelli Biosystems, Inc. has submitted 24 FDA 510(k) premarket notifications since 1993, of which 24 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Diphenylhydantoin, Radioimmunoassay (two-site Solid Phase), Ferritin, Radioassay, Triiodothyronine Uptake, Catalytic Methods, Amylase, Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine . Use the specialty filter in the sidebar to narrow results.

24 devices
1–24 of 24
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
K991733 · MRR System, Test, Low... · Chemistry
Jul 1999 53d
ACE T UPTAKE REAGENT TU CALIBRATORS
K981375 · KHQ Radioassay,... · Chemistry
Jun 1998 55d
ACE T4 REAGENT T4 CALIBRATORS
K981377 · KLI Enzyme Immunoassay,... · Chemistry
Jun 1998 55d
ACE VALPROIC ACID REAGENT, AED CALIBRATORS
K973581 · LEG Enzyme Immunoassay,... · Toxicology
Nov 1997 51d
ACE PRIMIDONE REAGENT, AED CALIBRATORS
K973582 · DJD Enzyme Immunoassay,... · Toxicology
Nov 1997 51d
ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS
K973583 · KLS Enzyme Immunoassay,... · Toxicology
Nov 1997 51d
ACE PHENOBARBITAL REAGENT/AED CALIBRATORS
K973536 · DLJ Calibrators, Drug Specific · Chemistry
Nov 1997 49d
ACE PHENYTOIN REAGENT, AED CALIBRATORS
K973414 · DIP Enzyme Immunoassay,... · Toxicology
Nov 1997 56d
ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
K973535 · KLT Enzyme Immunoassay,... · Chemistry
Oct 1997 32d
ACE HDL-C REAGENT
K971526 · LBS Ldl & Vldl Precipitation,... · Chemistry
May 1997 23d
HDL PRECIPITATING REAGENT
K954179 · LBR Ldl & Vldl Precipitation,... · Chemistry
Dec 1995 96d
TRIGLYCERIDES REAGENT
K954187 · JGY Colorimetric Method,... · Chemistry
Oct 1995 47d
MAGNESIUM REAGENT
K952426 · JGJ Photometric Method,... · Chemistry
Aug 1995 75d
ACE(TM) CEDIA(R) FERRITIN ASSAY
K950393 · JMG Radioimmunoassay... · Chemistry
May 1995 104d
ACE AMYLASE REAGENT
K951548 · JFJ Catalytic Methods, Amylase · Chemistry
May 1995 41d
ACE IRON REAGENT
K944911 · JIY Photometric Method, Iron... · Chemistry
Feb 1995 128d
ACE(TM) CEDIA(R) PHENYTOIN ASSAY
K944085 · DIP Enzyme Immunoassay,... · Chemistry
Dec 1994 128d
ACE CEDIA CORTISOL ASSAY
K943427 · CGR Radioimmunoassay, Cortisol · Chemistry
Nov 1994 136d
ACE CEDIA PHENOBARBITAL ASSAY
K942501 · DLZ Enzyme Immunoassay,... · Chemistry
Oct 1994 135d
ACE CLINICAL CHEMISTRY SYSTEM
K941489 · DIS Enzyme Immunoassay,... · Chemistry
Jul 1994 112d
ACE CLINICAL CHEMISTRY SYSTEM
K940267 · KXT Enzyme Immunoassay, Digoxin · Chemistry
May 1994 102d
ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)
K933862 · JGS Electrode, Ion Specific,... · Chemistry
Oct 1993 64d
ACE CLINICAL CHEMISTRY SYSTEM
K931786 · JJE Analyzer, Chemistry... · Chemistry
Sep 1993 165d
ACE CLINICAL CHEMISTRY SYSTEM
K930104 · JIX Calibrator, Multi-analyte... · Chemistry
Aug 1993 224d
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