FDA 510(k) Chemistry Devices
FDA 510(k) Chemistry Devices - Regulatory Overview
FDA 510(k) chemistry devices cover in vitro diagnostic (IVD) instruments used in clinical laboratories. The FDA review panel code is CH.
This category includes:
- Clinical chemistry analyzers - glucose, electrolytes, enzymes, proteins
- Point-of-care test systems - rapid diagnostics for hospital and home use
- Reagents and calibrators - consumables used with automated analyzers
- Urinalysis systems - dipstick readers and urine sediment analyzers
Most devices in this panel are Class II (Special Controls) under 21 CFR Part 862. Data sourced from FDA 510(k) public files. Updated monthly.
13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
Cleared
Jun 21, 2007
ST AIA-PACK INTACT PTH ASSAY
CEW
Radioimmunoassay, Parathyroid Hormone
199d
Cleared
Jun 19, 2007
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
CEW
Radioimmunoassay, Parathyroid Hormone
237d
Cleared
Jun 13, 2007
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
DIC
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
77d
Cleared
Jun 13, 2007
NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
NBW
System, Test, Blood Glucose, Over The Counter
138d
Cleared
Jun 12, 2007
CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
CGS
Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
272d
Cleared
Jun 05, 2007
ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL
CIX
Bromcresol Green Dye-binding, Albumin
469d
Cleared
Jun 04, 2007
OLYMPUS CK-MB REAGENT
JHY
Colorimetric Method, Cpk Or Isoenzymes
69d
Cleared
Jun 01, 2007
SYNCHRON SYSTEMS CREATININE REAGENT
CGX
Alkaline Picrate, Colorimetry, Creatinine
25d
Cleared
Jun 01, 2007
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
CGX
Alkaline Picrate, Colorimetry, Creatinine
25d
Cleared
Jun 01, 2007
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
CGX
Alkaline Picrate, Colorimetry, Creatinine
25d
Cleared
Jun 01, 2007
IMDX SYSTEMS
DJG
Enzyme Immunoassay, Opiates
170d
Cleared
May 25, 2007
VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927
JFY
Enzymatic Method, Creatinine
23d
Cleared
May 25, 2007
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
JFY
Enzymatic Method, Creatinine
23d
Cleared
May 25, 2007
ACCU-CHEK PERFORMA SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
85d
Cleared
May 25, 2007
MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
120d
Cleared
May 23, 2007
MODIFICATION TO SENTINEL CLIN CHEM CAL
JIX
Calibrator, Multi-analyte Mixture
47d
Cleared
May 22, 2007
AMYLASE EPS REAGENT
JFJ
Catalytic Methods, Amylase
137d
Cleared
May 09, 2007
ACCU-CHEK SMART PIX
NBW
System, Test, Blood Glucose, Over The Counter
266d
Cleared
May 07, 2007
TRACKRECORD DATA MANAGEMENT SOFTWARE
NBW
System, Test, Blood Glucose, Over The Counter
66d
Cleared
May 07, 2007
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
LCP
Assay, Glycosylated Hemoglobin
80d
Cleared
May 07, 2007
NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS
CGL
Electrode, Ion Based, Enzymatic, Creatinine
119d
Cleared
May 07, 2007
KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
287d
Cleared
May 04, 2007
CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3
JJY
Multi-analyte Controls, All Kinds (assayed)
49d
Cleared
May 04, 2007
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
NQD
Cardiac C-reactive Protein, Antigen, Antiserum, And Control
59d
Cleared
May 04, 2007
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
120d
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