FDA 510(k) Chemistry Devices
About Chemistry Devices
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.
13221
Total
13190
Cleared
88d
Avg days
1976
Since
264 Chemistry devices
Cleared
Feb 13, 2025
FaStep Pregnancy Rapid Test Cassette
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
28d
Cleared
Feb 10, 2025
Calcium2
CJY
Azo Dye, Calcium
42d
Cleared
Feb 07, 2025
Elecsys sFlt-1 and Elecsys PlGF
QWH
Prognostic Test For Development Or Progression Of Preeclampsia
261d
Cleared
Jan 31, 2025
Synthgene Home Test HCG Test Strip
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
193d
Cleared
Jan 30, 2025
TeleRPM Gen2 Blood Glucose Monitoring System
NBW
System, Test, Blood Glucose, Over The Counter
125d
Cleared
Jan 24, 2025
Tina-quant Lipoprotein(a) Gen.2 Molarity
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
268d
Cleared
Jan 16, 2025
Alere NT-proBNP for Alinity i Reagent Kit
NBC
Test, Natriuretic Peptide
262d
Cleared
Jan 15, 2025
FaStep Early Pregnancy Rapid Test Strip
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
57d
Cleared
Jan 14, 2025
ABL90 FLEX PLUS System
CEM
Electrode, Ion Specific, Potassium
273d
Cleared
Jan 10, 2025
Safecare Urinary Tract Infection Test
JMT
Diazo (colorimetric), Nitrite (urinary, Non-quant)
119d
Cleared
Jan 03, 2025
i-STAT hs-TnI cartridge with the i-STAT 1 System
MMI
Immunoassay Method, Troponin Subunit
268d
Cleared
Dec 20, 2024
iHealth® Early Pregnancy Test
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
218d
Cleared
Dec 13, 2024
ABL90 FLEX PLUS System
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
246d
Cleared
Dec 11, 2024
EndoTool IV (3.1)
NDC
Calculator, Drug Dose
236d
Cleared
Dec 04, 2024
Atellica® CH Creatinine_3 (Crea3)
CGX
Alkaline Picrate, Colorimetry, Creatinine
89d
Cleared
Nov 22, 2024
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
LCP
Assay, Glycosylated Hemoglobin
931d
Cleared
Nov 19, 2024
Nova Allegro UACR Assay, Nova Allegro Analyzer
CGX
Alkaline Picrate, Colorimetry, Creatinine
881d
Cleared
Nov 19, 2024
XPER Technology PREMIUM Pro Blood Glucose Monitoring System
PZI
Prescription Use Blood Glucose Meter For Near-patient Testing
925d
Cleared
Nov 13, 2024
CeQur Simplicity™ On-Demand Insulin Delivery System
OPP
Pump, Infusion, Insulin Bolus
28d
Cleared
Nov 12, 2024
InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
NDC
Calculator, Drug Dose
60d
Cleared
Nov 04, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
NBW
System, Test, Blood Glucose, Over The Counter
243d
Cleared
Oct 23, 2024
IDS-iSYS Free Testosterone
CDZ
Radioimmunoassay, Testosterones And Dihydrotestosterone
209d
Cleared
Oct 16, 2024
Alkaline Phosphatase
CJE
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
239d
Cleared
Oct 11, 2024
HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
255d
Cleared
Oct 08, 2024
Sejoy Blood Glucose Monitoring System
NBW
System, Test, Blood Glucose, Over The Counter
216d
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