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
11192 Chemistry devices
Cleared
May 12, 2011
ELECSYS PROLACTIN II CALCHECK 5
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
70d
Cleared
May 12, 2011
CLEARBLUE EASY PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
86d
Cleared
May 12, 2011
DROPPER A1C DIABETES CONTROL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
140d
Cleared
May 12, 2011
ROCHE ELECSYS FOLATE RBC
CGN
Acid, Folic, Radioimmunoassay
142d
Cleared
May 11, 2011
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
CDD
Radioassay, Vitamin B12
86d
Cleared
May 06, 2011
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
JJY
Multi-analyte Controls, All Kinds (assayed)
171d
Cleared
May 06, 2011
URIC ACID MODEL 3P39
KNK
Acid, Uric, Uricase (colorimetric)
241d
Cleared
Apr 28, 2011
IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
132d
Cleared
Apr 28, 2011
AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
NBW
System, Test, Blood Glucose, Over The Counter
241d
Cleared
Apr 27, 2011
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
CGA
Glucose Oxidase, Glucose
118d
Cleared
Apr 27, 2011
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
DCK
C-reactive Protein, Antigen, Antiserum, And Control
146d
Cleared
Apr 22, 2011
GSP NEONATAL THYROXINE (T4)
KLI
Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
147d
Cleared
Apr 21, 2011
EASYRA UREA NITROGEN AND CREATININE REAGENTS
CDQ
Urease And Glutamic Dehydrogenase, Urea Nitrogen
42d
Cleared
Apr 20, 2011
UCP DRUG SCREENING TEST CUPS
DIS
Enzyme Immunoassay, Barbiturate
56d
Cleared
Apr 20, 2011
FDI GLUCOSE CONTROL SOLUTION FOR AVIVA
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
64d
Cleared
Apr 08, 2011
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
LAF
Gas Chromatography, Methamphetamine
290d
Cleared
Apr 08, 2011
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
DKB
Calibrators, Drug Mixture
290d
Cleared
Apr 08, 2011
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
LCM
Enzyme Immunoassay, Phencyclidine
290d
Cleared
Apr 08, 2011
THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
DKZ
Enzyme Immunoassay, Amphetamine
290d
Cleared
Apr 08, 2011
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
LDJ
Enzyme Immunoassay, Cannabinoids
290d
Cleared
Apr 07, 2011
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
JIT
Calibrator, Secondary
77d
Cleared
Apr 04, 2011
EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
CIX
Bromcresol Green Dye-binding, Albumin
350d
Cleared
Mar 24, 2011
ABL835 FLEX ANALYZER WITH PLEURAL PH
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
38d
Cleared
Mar 18, 2011
EMIT II PLUS6-ACETYLMORPHINE ASSAY
DJG
Enzyme Immunoassay, Opiates
175d
Cleared
Mar 16, 2011
IDS-ISYS IFG-I CONTROL SET
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
30d
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