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
Jan 14, 2011
AUDIT MICROCV PROTEIN LINEARITY SET
JJY
Multi-analyte Controls, All Kinds (assayed)
259d
Cleared
Jan 14, 2011
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
JGS
Electrode, Ion Specific, Sodium
296d
Cleared
Jan 10, 2011
AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
JJY
Multi-analyte Controls, All Kinds (assayed)
122d
Cleared
Jan 07, 2011
ELECSYS DHEA-S CALCHECK 5
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
49d
Cleared
Jan 07, 2011
ON CALL PLUS DIABETES MONITORING SOFTWARE
NBW
System, Test, Blood Glucose, Over The Counter
235d
Cleared
Jan 07, 2011
OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
444d
Cleared
Jan 03, 2011
PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115
NOE
Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2
186d
Cleared
Dec 28, 2010
LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY
DKZ
Enzyme Immunoassay, Amphetamine
145d
Cleared
Dec 23, 2010
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
JIT
Calibrator, Secondary
52d
Cleared
Dec 23, 2010
AUDIT MICROCV HS-CRP LINEARITY SET
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
216d
Cleared
Dec 23, 2010
AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
286d
Cleared
Dec 21, 2010
LIPID CONTROLS
JJY
Multi-analyte Controls, All Kinds (assayed)
92d
Cleared
Dec 21, 2010
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
NBW
System, Test, Blood Glucose, Over The Counter
260d
Cleared
Dec 17, 2010
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL
JIT
Calibrator, Secondary
31d
Cleared
Dec 16, 2010
GSP NEONATAL IRT KIT (3306-001U)
JNO
N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin
113d
Cleared
Dec 15, 2010
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
CGA
Glucose Oxidase, Glucose
294d
Cleared
Dec 15, 2010
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
KHS
Enzymatic, Carbon-dioxide
338d
Cleared
Dec 10, 2010
ABL837 FLEX ANALYZER
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
267d
Cleared
Dec 06, 2010
PRECICONTROL HBA1C NORM
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
47d
Cleared
Nov 30, 2010
DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS
JIT
Calibrator, Secondary
77d
Cleared
Nov 23, 2010
ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
53d
Cleared
Nov 18, 2010
ELECSYS PTH CALCHECK 5
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
22d
Cleared
Nov 17, 2010
BGM GALECTIN -3
OSX
Galectin-3 In Vitro Diagnostic Assay
345d
Cleared
Nov 09, 2010
VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
26d
Cleared
Oct 22, 2010
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT
CEW
Radioimmunoassay, Parathyroid Hormone
105d
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