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
11190 Chemistry devices
Cleared
Jul 05, 2011
VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
JJY
Multi-analyte Controls, All Kinds (assayed)
97d
Cleared
Jul 01, 2011
FORA POCT MANAGMENT SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
79d
Cleared
Jun 29, 2011
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
JJY
Multi-analyte Controls, All Kinds (assayed)
118d
Cleared
Jun 28, 2011
VITAL SERUM CONTROLS
JJY
Multi-analyte Controls, All Kinds (assayed)
71d
Cleared
Jun 28, 2011
INDIKO
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
174d
Cleared
Jun 27, 2011
U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
391d
Cleared
Jun 23, 2011
LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
LDJ
Enzyme Immunoassay, Cannabinoids
148d
Cleared
Jun 21, 2011
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO
CIX
Bromcresol Green Dye-binding, Albumin
88d
Cleared
Jun 21, 2011
EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
NBW
System, Test, Blood Glucose, Over The Counter
306d
Cleared
Jun 20, 2011
IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
82d
Cleared
Jun 10, 2011
ABBOTT ARCHITECT LH CALIBRATORS
JIT
Calibrator, Secondary
58d
Cleared
Jun 10, 2011
AUTODELFIA NEONATAL IRT KIT
JNO
N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin
130d
Cleared
Jun 10, 2011
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
JJY
Multi-analyte Controls, All Kinds (assayed)
184d
Cleared
Jun 09, 2011
ELECSYS SHBG CALCHECK 5
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
27d
Cleared
Jun 09, 2011
ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
JIX
Calibrator, Multi-analyte Mixture
118d
Cleared
May 27, 2011
FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
84d
Cleared
May 27, 2011
CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
310d
Cleared
May 25, 2011
SYNCHRON MULTI CALIBRATOR
JIX
Calibrator, Multi-analyte Mixture
117d
Cleared
May 23, 2011
EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
LFR
Glucose Dehydrogenase, Glucose
404d
Cleared
May 20, 2011
CANNABINOIDS URINE TEST
LDJ
Enzyme Immunoassay, Cannabinoids
119d
Cleared
May 20, 2011
EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
CJE
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
396d
Cleared
May 19, 2011
ARK CARE DIABETES MANAGMENT SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
66d
Cleared
May 17, 2011
DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
LCP
Assay, Glycosylated Hemoglobin
113d
Cleared
May 13, 2011
HEALTH CARE SYSTEM SOFTWARE
NBW
System, Test, Blood Glucose, Over The Counter
39d
Cleared
May 13, 2011
DIMENSIONS HB1C KIT, MODEL DF105A
LCP
Assay, Glycosylated Hemoglobin
259d
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