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
Apr 29, 2014
ACCU-CHEK AVIVA PLUS SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
131d
Cleared
Apr 28, 2014
GSP NEONATAL TOTAL GALACTOSE KIT
JIA
Enzymatic Methods, Galactose
152d
Cleared
Apr 28, 2014
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
LFR
Glucose Dehydrogenase, Glucose
161d
Cleared
Apr 18, 2014
ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
259d
Cleared
Apr 17, 2014
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
NBW
System, Test, Blood Glucose, Over The Counter
153d
Cleared
Apr 17, 2014
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
CFR
Hexokinase, Glucose
356d
Cleared
Apr 15, 2014
EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
161d
Cleared
Apr 10, 2014
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
JIT
Calibrator, Secondary
28d
Cleared
Apr 10, 2014
ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
195d
Cleared
Apr 08, 2014
WUNDER PREGNANCY TEST
JHI
Visual, Pregnancy Hcg, Prescription Use
410d
Cleared
Apr 04, 2014
A1C GEAR SYSTEM
LCP
Assay, Glycosylated Hemoglobin
457d
Cleared
Apr 01, 2014
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
28d
Cleared
Mar 31, 2014
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
32d
Cleared
Mar 28, 2014
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS
LCP
Assay, Glycosylated Hemoglobin
149d
Cleared
Mar 27, 2014
ELECSYS PRECICONTROL TS
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
23d
Cleared
Mar 27, 2014
PATHFAST CTNL CALIBRATORS
JIT
Calibrator, Secondary
385d
Cleared
Mar 25, 2014
RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
JJY
Multi-analyte Controls, All Kinds (assayed)
39d
Cleared
Mar 25, 2014
NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
287d
Cleared
Mar 21, 2014
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
CHH
Enzymatic Esterase--oxidase, Cholesterol
246d
Cleared
Mar 14, 2014
DIAZYME 25-OH VITAMIN D ASSAY
MRG
System, Test, Vitamin D
127d
Cleared
Mar 14, 2014
FREND TSH (REAGENT CARTRIDGE)
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
260d
Cleared
Mar 11, 2014
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
KHS
Enzymatic, Carbon-dioxide
40d
Cleared
Mar 10, 2014
ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
35d
Cleared
Mar 06, 2014
AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
CGA
Glucose Oxidase, Glucose
265d
Cleared
Mar 05, 2014
IMMULITE 2000 DHEA-SO4
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
30d
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