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
11183 Chemistry devices
Cleared
Aug 09, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
JFJ
Catalytic Methods, Amylase
149d
Cleared
Aug 08, 2013
COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY
PDJ
Hemoglobin A1c Test System
433d
Cleared
Aug 02, 2013
SOFIA(R) HCG FIA
JHI
Visual, Pregnancy Hcg, Prescription Use
100d
Cleared
Jul 31, 2013
GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
187d
Cleared
Jul 31, 2013
ABL90 FLEX
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
190d
Cleared
Jul 30, 2013
BROADMASTER HEALTHCARE SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
144d
Cleared
Jul 26, 2013
HBA1C CONTROL, LEVEL 1 AND LEVEL 2
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
28d
Cleared
Jul 26, 2013
CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
29d
Cleared
Jul 26, 2013
EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM
JJY
Multi-analyte Controls, All Kinds (assayed)
53d
Cleared
Jul 18, 2013
ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
31d
Cleared
Jul 17, 2013
COBAS C BILIRUBIN TOTAL GEN.3
CIG
Diazo Colorimetry, Bilirubin
49d
Cleared
Jul 17, 2013
25-OH VITAMIN D ELISA
MRG
System, Test, Vitamin D
231d
Cleared
Jul 15, 2013
LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE
NBW
System, Test, Blood Glucose, Over The Counter
125d
Cleared
Jul 15, 2013
25OH VITAMIN D TOTAL ELISA TEST
MRG
System, Test, Vitamin D
256d
Cleared
Jul 03, 2013
FASTPACK VITAMIN D
MRG
System, Test, Vitamin D
189d
Cleared
Jul 03, 2013
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
CJY
Azo Dye, Calcium
267d
Cleared
Jun 28, 2013
SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
221d
Cleared
Jun 27, 2013
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
168d
Cleared
Jun 26, 2013
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
JIT
Calibrator, Secondary
28d
Cleared
Jun 21, 2013
LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.
NBW
System, Test, Blood Glucose, Over The Counter
135d
Cleared
Jun 20, 2013
SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
JIA
Enzymatic Methods, Galactose
435d
Cleared
Jun 19, 2013
VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
265d
Cleared
Jun 18, 2013
IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D
MRG
System, Test, Vitamin D
244d
Cleared
Jun 18, 2013
TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
260d
Cleared
Jun 18, 2013
VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS
NBW
System, Test, Blood Glucose, Over The Counter
264d
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