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
11178 Chemistry devices
Cleared
May 13, 2015
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
JXM
Enzyme Immunoassay, Benzodiazepine
90d
Cleared
May 13, 2015
Hematocrit and Metabolite QUALICHECK
JJS
Controls For Blood-gases, (assayed And Unassayed)
100d
Cleared
May 11, 2015
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
KQO
Automated Urinalysis System
243d
Cleared
May 07, 2015
MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System
CGA
Glucose Oxidase, Glucose
127d
Cleared
May 07, 2015
FORA GD43 Blood Glucose Monitoring System
NBW
System, Test, Blood Glucose, Over The Counter
154d
Cleared
May 06, 2015
StatStrip Glucose Hospital Meter
PZI
Prescription Use Blood Glucose Meter For Near-patient Testing
90d
Cleared
May 01, 2015
Elecsys Progesterone III Cal Check 5
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
22d
Cleared
May 01, 2015
ADVIA Centaur TSH3-Ultra
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
72d
Cleared
May 01, 2015
BGM009 BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
374d
Cleared
Apr 30, 2015
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
JIR
Indicator Method, Protein Or Albumin (urinary, Non-quant.)
79d
Cleared
Apr 30, 2015
VALIDATE Anemia Calibration Verification/ Linearity Test Kit
JJY
Multi-analyte Controls, All Kinds (assayed)
198d
Cleared
Apr 22, 2015
ADVIA CENTAUR TSH
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
273d
Cleared
Apr 21, 2015
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
CJM
Radioimmunoassay, Aldosterone
187d
Cleared
Apr 20, 2015
I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
602d
Cleared
Apr 16, 2015
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
DHA
System, Test, Human Chorionic Gonadotropin
569d
Cleared
Apr 15, 2015
PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
274d
Cleared
Apr 13, 2015
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
82d
Cleared
Apr 10, 2015
AUTION CHECK PLUS
JJW
Urinalysis Controls (assayed And Unassayed)
239d
Cleared
Apr 02, 2015
Total Bilirubin
CIG
Diazo Colorimetry, Bilirubin
34d
Cleared
Mar 31, 2015
ADVIA Centaur Cortisol (COR) Assy
JFT
Fluorometric, Cortisol
189d
Cleared
Mar 30, 2015
IDS-iSYS CTX-I Calibration Verifiers
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
131d
Cleared
Mar 26, 2015
TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System
NBW
System, Test, Blood Glucose, Over The Counter
73d
Cleared
Mar 24, 2015
VARIANT II TURBO HbA1c Kit - 2.0
PDJ
Hemoglobin A1c Test System
203d
Cleared
Mar 13, 2015
Liquichek Maternal Serum II Control
JJY
Multi-analyte Controls, All Kinds (assayed)
108d
Cleared
Mar 13, 2015
HOME ACCESS AIC TEST
LCP
Assay, Glycosylated Hemoglobin
239d
Looking for a specific chemistry device? Search by device name, K-number or manufacturer.
Search all Chemistry 510(k) devices