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.
13224
Total
13193
Cleared
208d
Avg (2y)
1976
Since
3201 Chemistry devices
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469
DIF
Drug Mixture Control Materials
26d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467
DIF
Drug Mixture Control Materials
26d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
DIF
Drug Mixture Control Materials
26d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
DIF
Drug Mixture Control Materials
27d
Cleared
May 24, 2002
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
JJT
Enzyme Controls (assayed And Unassayed)
15d
Cleared
May 09, 2002
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
MRR
System, Test, Low Density, Lipoprotein
64d
Cleared
May 08, 2002
DIMENSION ALDL CALIBRATOR, MODEL DC131
JIT
Calibrator, Secondary
63d
Cleared
May 06, 2002
SPIFE 2000/3000 ALP 40, 20
CIN
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
69d
Cleared
Apr 22, 2002
LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
DIE
Heavy Metals Control Materials
56d
Cleared
Mar 29, 2002
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
CFE
Electrophoretic, Lactate Dehydrogenase Isoenzymes
45d
Cleared
Mar 21, 2002
DIABETES ASSISTANT SOFTWARE
CGA
Glucose Oxidase, Glucose
94d
Cleared
Mar 01, 2002
MODIFICATION TO VIGIL LIPID CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
10d
Cleared
Feb 28, 2002
SOF-TACT DIABETES MANAGEMENT SYSYEM
NBW
System, Test, Blood Glucose, Over The Counter
176d
Cleared
Jan 28, 2002
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
MRR
System, Test, Low Density, Lipoprotein
46d
Cleared
Jan 18, 2002
N LATEX LP(A)
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
121d
Cleared
Jan 15, 2002
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
JFJ
Catalytic Methods, Amylase
43d
Cleared
Dec 21, 2001
SPIFE 2000/3000 LIPOPROTEIN
JHO
Electrophoretic Separation, Lipoproteins
64d
Cleared
Dec 18, 2001
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
JFL
Ph Rate Measurement, Carbon-dioxide
11d
Cleared
Dec 05, 2001
ACCU-CHEK ACTIVE TEST SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
135d
Cleared
Nov 20, 2001
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
CEW
Radioimmunoassay, Parathyroid Hormone
25d
Cleared
Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN VER.2
DER
Alpha-1-lipoprotein, Antigen, Antiserum, Control
49d
Cleared
Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
52d
Cleared
Nov 15, 2001
TINA-QUANT APOLIPOPROTEIN A-1 VER.2
DEL
Lipoprotein X, Antigen, Antiserum, Control
45d
Cleared
Nov 15, 2001
DIMENSION HAIC ASSAY, MODEL DF105
LCP
Assay, Glycosylated Hemoglobin
156d
Cleared
Nov 13, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
49d
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