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
Aug 01, 2019
MAGLUMI 2000 25-OH Vitamin D
MRG
System, Test, Vitamin D
56d
Cleared
Jul 30, 2019
Atellica CH Amylase_2 (AMY_2)
JFJ
Catalytic Methods, Amylase
60d
Cleared
Jul 29, 2019
Quantisal II Oral Fluid Collection Device
PJD
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
269d
Cleared
Jul 26, 2019
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
CJY
Azo Dye, Calcium
63d
Cleared
Jul 26, 2019
ACR LAB Urine Analysis Test System
JFY
Enzymatic Method, Creatinine
329d
Cleared
Jul 19, 2019
Stat Profile Prime ES Comp Plus Analyzer System
JGS
Electrode, Ion Specific, Sodium
58d
Cleared
Jul 18, 2019
DreaMed Advisor Pro
QCC
Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
57d
Cleared
Jun 28, 2019
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System
QBJ
Integrated Continuous Glucose Monitoring System, Factory Calibrated
28d
Cleared
Jun 17, 2019
IDS SHBG
CDZ
Radioimmunoassay, Testosterones And Dihydrotestosterone
143d
Cleared
Jun 12, 2019
On Call Express Voice Blood Glucose Monitoring System
NBW
System, Test, Blood Glucose, Over The Counter
55d
Cleared
Jun 12, 2019
LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
JGS
Electrode, Ion Specific, Sodium
687d
Cleared
Jun 07, 2019
VITROS XT Chemistry Products ALB-TP Slides
CIX
Bromcresol Green Dye-binding, Albumin
23d
Cleared
Jun 04, 2019
TD-4183 Blood Glucose Monitoring System
NBW
System, Test, Blood Glucose, Over The Counter
90d
Cleared
Jun 02, 2019
Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB
NBW
System, Test, Blood Glucose, Over The Counter
89d
Cleared
May 17, 2019
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
MMI
Immunoassay Method, Troponin Subunit
63d
Cleared
May 15, 2019
VeriClear Digital Early Result Pregnancy Test
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
261d
Cleared
May 08, 2019
GlucoLeader Enhance Blood Glucose Monitoring System
NBW
System, Test, Blood Glucose, Over The Counter
244d
Cleared
May 07, 2019
cobas u 601 urinalysis test system
JIL
Method, Enzymatic, Glucose (urinary, Non-quantitative)
147d
Cleared
May 03, 2019
NeoLSD MSMS Kit
PQW
Alpha-d-galactosidase A (gla) Newborn Screening Test System
84d
Cleared
May 02, 2019
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
JFJ
Catalytic Methods, Amylase
234d
Cleared
Apr 26, 2019
VITROS XT Chemistry Products TBIL-ALKP Slides
CIG
Diazo Colorimetry, Bilirubin
28d
Cleared
Apr 17, 2019
SEKURE Creatine Kinase Assay
CGS
Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
202d
Cleared
Apr 16, 2019
Elecsys TSH
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
21d
Cleared
Apr 15, 2019
WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
27d
Cleared
Apr 12, 2019
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
LCP
Assay, Glycosylated Hemoglobin
269d
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