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.
13237
Total
13205
Cleared
191d
Avg (2y)
1976
Since
11190 Chemistry devices
Cleared
Dec 02, 2011
ORAGENE-DX OGD-500
OYJ
Dna Specimen Collection, Saliva
263d
Cleared
Dec 01, 2011
RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
JJY
Multi-analyte Controls, All Kinds (assayed)
108d
Cleared
Dec 01, 2011
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
CKG
Radioimmunoassay, Acth
203d
Cleared
Dec 01, 2011
PRESTIGE 24I
CFR
Hexokinase, Glucose
365d
Cleared
Nov 23, 2011
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
MRG
System, Test, Vitamin D
265d
Cleared
Nov 23, 2011
ROM PLUS
NQM
Immunoassay For Detection Of Amniotic Fluid Protein(s).
266d
Cleared
Nov 22, 2011
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
29d
Cleared
Nov 22, 2011
DIMENSION CLINICAL CHEMISTRY SYSTEM
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
46d
Cleared
Nov 22, 2011
TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
NBW
System, Test, Blood Glucose, Over The Counter
48d
Cleared
Nov 22, 2011
PREMIER HB9210 HBA1C ANALYZER
LCP
Assay, Glycosylated Hemoglobin
132d
Cleared
Nov 21, 2011
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
DJZ
Devices, Breath Trapping, Alcohol
263d
Cleared
Nov 18, 2011
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS
KHS
Enzymatic, Carbon-dioxide
130d
Cleared
Nov 18, 2011
ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL
JFY
Enzymatic Method, Creatinine
366d
Cleared
Nov 10, 2011
IGLUCOSE SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
125d
Cleared
Nov 09, 2011
CPK REAGENT
CGS
Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
79d
Cleared
Nov 09, 2011
SWEETSPOT DIABETES DATA MANAGEMENT SERVICE
NBW
System, Test, Blood Glucose, Over The Counter
161d
Cleared
Nov 08, 2011
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
CFR
Hexokinase, Glucose
316d
Cleared
Nov 04, 2011
POLY-CHEM 90 ISE MODULE
CEM
Electrode, Ion Specific, Potassium
74d
Cleared
Nov 04, 2011
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
NDW
Assay, Porphyrin, Spectrophotometry, Lithium
101d
Cleared
Nov 04, 2011
ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
388d
Cleared
Nov 03, 2011
THERMO SCIENTIFIC MAS OMNI-CORE
JJY
Multi-analyte Controls, All Kinds (assayed)
231d
Cleared
Oct 28, 2011
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM
CGA
Glucose Oxidase, Glucose
357d
Cleared
Oct 20, 2011
EASTLYTE NA/K/CA/PH
CEM
Electrode, Ion Specific, Potassium
24d
Cleared
Oct 18, 2011
ELECSYS T4 CALCHECK 5
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
48d
Cleared
Oct 14, 2011
ADVIA CENTAUR VITAMIN D TOTAL ASSAY
MRG
System, Test, Vitamin D
227d
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