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.
13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
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 19, 2011
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
CDT
Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
223d
Cleared
May 19, 2011
ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL
LCP
Assay, Glycosylated Hemoglobin
448d
Cleared
May 17, 2011
DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
LCP
Assay, Glycosylated Hemoglobin
113d
Cleared
May 16, 2011
PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
MMI
Immunoassay Method, Troponin Subunit
482d
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
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
Looking for a specific chemistry device? Search by device name, K-number or manufacturer.
Search all Chemistry 510(k) devices