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
11171 Chemistry devices
Cleared
Oct 01, 2020
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
CEM
Electrode, Ion Specific, Potassium
212d
Cleared
Sep 30, 2020
IDS-iSYS Ostase BAP
CIN
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
217d
Cleared
Sep 25, 2020
BD Preset Syringe & BD A-Line Syringe
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
30d
Cleared
Sep 11, 2020
GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System
NBW
System, Test, Blood Glucose, Over The Counter
284d
Cleared
Sep 09, 2020
KetoSens BT Blood B-Ketone Monitoring System
JIN
Nitroprusside, Ketones (urinary, Non-quant.)
92d
Cleared
Sep 09, 2020
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
CHW
Titrimetric With Edta And Indicator, Calcium
348d
Cleared
Aug 28, 2020
DreaMed Advisor Pro
QCC
Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
86d
Cleared
Aug 24, 2020
ST AIA-PACK BNP
NBC
Test, Natriuretic Peptide
360d
Cleared
Aug 20, 2020
Distinct® Early Detection Pregnancy Test
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
262d
Cleared
Aug 17, 2020
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
QDJ
Direct-to-consumer Access Pharmacogenetic Assessment System
244d
Cleared
Aug 13, 2020
hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
205d
Cleared
Aug 13, 2020
AncestryDNA Saliva Collection Kit
OYJ
Dna Specimen Collection, Saliva
300d
Cleared
Aug 11, 2020
Pointe Scientific Creatinine Kinase (CK) Reagent Set
CGS
Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
455d
Cleared
Aug 07, 2020
LZI Fentanyl II Enzyme Immunoassay
DJG
Enzyme Immunoassay, Opiates
25d
Cleared
Aug 07, 2020
EndoTool IV System
NDC
Calculator, Drug Dose
53d
Not Cleared
Aug 07, 2020
Cell-Free DNA BCT
QMA
Blood Collection Device For Cell-free Nucleic Acid
210d
Cleared
Jul 28, 2020
Quantisal Oral Fluid Collection Device
PJD
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
123d
Cleared
Jun 16, 2020
Control-IQ Technology
QJI
Interoperable Automated Glycemic Controller
111d
Cleared
Jun 12, 2020
FreeStyle Libre 2 Flash Glucose Monitoring System
QLG
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
190d
Cleared
Jun 05, 2020
epoc Blood Analysis System
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
140d
Cleared
Jun 05, 2020
VivaChek Blood Glucose and B-Ketone Monitoring System
JIN
Nitroprusside, Ketones (urinary, Non-quant.)
228d
Cleared
Jun 04, 2020
t:slim X2 Insulin Pump with Interoperable Technology
QFG
Alternate Controller Enabled Insulin Infusion Pump
30d
Cleared
Jun 04, 2020
Livongo Blood Glucose Monitoring System (BG1000)
NBW
System, Test, Blood Glucose, Over The Counter
121d
Cleared
May 29, 2020
ADVIA Centaur Vitamin D Total (VitD)
MRG
System, Test, Vitamin D
88d
Cleared
May 06, 2020
LIAISON® Folate
CGN
Acid, Folic, Radioimmunoassay
230d
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