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.
13224
Total
13193
Cleared
208d
Avg (2y)
1976
Since
3201 Chemistry devices
Cleared
Dec 23, 2005
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
NQD
Cardiac C-reactive Protein, Antigen, Antiserum, And Control
49d
Cleared
Dec 23, 2005
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
JIS
Calibrator, Primary
49d
Cleared
Dec 16, 2005
ARCHITECT B12 CALIBRATORS
JIT
Calibrator, Secondary
15d
Cleared
Dec 16, 2005
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
JFM
Enzymatic Method, Bilirubin
44d
Cleared
Dec 14, 2005
ISE INDIRECT NA, K, CL FOR GEN.2
JGS
Electrode, Ion Specific, Sodium
30d
Cleared
Dec 09, 2005
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
25d
Cleared
Dec 05, 2005
ELECSYS PROBNP IMMUNOASSAY
NBC
Test, Natriuretic Peptide
192d
Cleared
Nov 09, 2005
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
GGM
Control, Hemoglobin
33d
Cleared
Oct 21, 2005
GEM PREMIER 3000
CGA
Glucose Oxidase, Glucose
77d
Cleared
Oct 17, 2005
ELECSYS PRECICONTROL BONE
JJY
Multi-analyte Controls, All Kinds (assayed)
129d
Cleared
Sep 30, 2005
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
LCP
Assay, Glycosylated Hemoglobin
22d
Cleared
Sep 08, 2005
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK
JHX
Fluorometric Method, Cpk Or Isoenzymes
79d
Cleared
Sep 08, 2005
ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK
NEO
System, Test, Osteocalcin
113d
Cleared
Sep 02, 2005
MODIFICATION TO ACCU-CHEK GO SYSTEM
LFR
Glucose Dehydrogenase, Glucose
79d
Cleared
Aug 25, 2005
ULTRA HDL
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
37d
Cleared
Aug 22, 2005
IRON STANDARD
JIT
Calibrator, Secondary
28d
Cleared
Aug 03, 2005
ABBOTT AXSYM B12
CDD
Radioassay, Vitamin B12
75d
Cleared
Jul 25, 2005
ELECSYS PRECICONTROL UNIVERSAL
JJY
Multi-analyte Controls, All Kinds (assayed)
32d
Cleared
Jul 11, 2005
DIMENSION VISTA INTEGRATED SYSTEM
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
74d
Cleared
Jul 05, 2005
ELECSYS PRECICONTROL ANEMIA
JJY
Multi-analyte Controls, All Kinds (assayed)
27d
Cleared
Jun 17, 2005
ELECSYS RBC FOLATE HEMOLYZED REAGENT
CGN
Acid, Folic, Radioimmunoassay
30d
Cleared
Jun 13, 2005
SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
JXM
Enzyme Immunoassay, Benzodiazepine
25d
Cleared
May 02, 2005
ACCU-CHEK INTEGRA SYSTEM
LFR
Glucose Dehydrogenase, Glucose
26d
Cleared
Apr 27, 2005
LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS
JJY
Multi-analyte Controls, All Kinds (assayed)
56d
Cleared
Apr 27, 2005
ACCU-CHEK AVIVA SYSTEM
LFR
Glucose Dehydrogenase, Glucose
132d
Looking for a specific chemistry device? Search by device name, K-number or manufacturer.
Search all Chemistry 510(k) devices