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
181d
Avg (2y)
1976
Since
11214 Chemistry devices
Cleared
Jun 06, 2003
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
DCK
C-reactive Protein, Antigen, Antiserum, And Control
165d
Cleared
Jun 02, 2003
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
CFR
Hexokinase, Glucose
54d
Cleared
May 30, 2003
MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3
JJY
Multi-analyte Controls, All Kinds (assayed)
30d
Cleared
May 12, 2003
ELECSYS LH CALSET II
JIT
Calibrator, Secondary
18d
Cleared
May 12, 2003
RANDOX AMMONIA
JIF
Enzymatic Method, Ammonia
53d
Cleared
May 02, 2003
CLEARBLUE EASY DIGITAL PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
60d
Cleared
May 02, 2003
GLYCA-DIRECT FRUCTOSAMINE
LCP
Assay, Glycosylated Hemoglobin
184d
Cleared
Apr 28, 2003
MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
33d
Cleared
Apr 28, 2003
MICROALBUMIN REAGENT SET AND CALIBRATORS
DDZ
Albumin, Fitc, Antigen, Antiserum, Control
159d
Cleared
Apr 23, 2003
PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO
NBW
System, Test, Blood Glucose, Over The Counter
205d
Cleared
Apr 11, 2003
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
JIS
Calibrator, Primary
71d
Cleared
Apr 10, 2003
BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR
JIX
Calibrator, Multi-analyte Mixture
28d
Cleared
Apr 09, 2003
BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
27d
Cleared
Mar 31, 2003
G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
JBF
Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening
117d
Cleared
Mar 26, 2003
CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL
JJY
Multi-analyte Controls, All Kinds (assayed)
20d
Cleared
Mar 21, 2003
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
JJT
Enzyme Controls (assayed And Unassayed)
10d
Cleared
Mar 18, 2003
WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006
JIX
Calibrator, Multi-analyte Mixture
84d
Cleared
Mar 18, 2003
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
KNK
Acid, Uric, Uricase (colorimetric)
264d
Cleared
Mar 17, 2003
SAS RSV CONTROL KIT
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
18d
Cleared
Mar 14, 2003
MAS LIPID LEVEL 1 AND 2
JJY
Multi-analyte Controls, All Kinds (assayed)
10d
Cleared
Mar 13, 2003
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS
JJY
Multi-analyte Controls, All Kinds (assayed)
17d
Cleared
Mar 06, 2003
URS-1B (BLOOD TEST)
JIO
Blood, Occult, Colorimetric, In Urine
155d
Cleared
Mar 03, 2003
BAYER LIGAND PLUS 1, 2, 3 CONTROLS
JJY
Multi-analyte Controls, All Kinds (assayed)
20d
Cleared
Mar 03, 2003
ASCENSIA BREEZE BLOOD GLUCOSE METER
CGA
Glucose Oxidase, Glucose
84d
Cleared
Feb 25, 2003
FIRST RESPONSE PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
32d
Looking for a specific chemistry device? Search by device name, K-number or manufacturer.
Search all Chemistry 510(k) devices