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
Jan 23, 2012
RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
JJY
Multi-analyte Controls, All Kinds (assayed)
332d
Cleared
Jan 20, 2012
LIAISON 25 OH VITAMIN D TOTAL ASSAY
MRG
System, Test, Vitamin D
122d
Cleared
Jan 20, 2012
AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..
KHO
Fluorometer, For Clinical Use
177d
Cleared
Jan 18, 2012
MISSION U500 URINE ANALYZER
JIO
Blood, Occult, Colorimetric, In Urine
261d
Cleared
Jan 18, 2012
AG-608N BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
380d
Cleared
Jan 17, 2012
AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III
NBW
System, Test, Blood Glucose, Over The Counter
90d
Cleared
Jan 06, 2012
GLUCOSE TEST SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
74d
Cleared
Jan 05, 2012
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
KHP
Acid, Lactic, Enzymatic Method
93d
Cleared
Dec 30, 2011
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
JIT
Calibrator, Secondary
44d
Cleared
Dec 29, 2011
ELITTECH CLINICAL SYSTEMS ALP IFCC SL
CJE
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
55d
Cleared
Dec 23, 2011
EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
LFR
Glucose Dehydrogenase, Glucose
81d
Cleared
Dec 23, 2011
AU5800(R) CHEMISTRY ANALYZER
CEM
Electrode, Ion Specific, Potassium
123d
Cleared
Dec 23, 2011
GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
129d
Cleared
Dec 23, 2011
ROCHE ACETAMINOPHEN ASSAY
LDP
Colorimetry, Acetaminophen
282d
Cleared
Dec 23, 2011
TINA-QUANT HBA1C GEN.2
LCP
Assay, Glycosylated Hemoglobin
324d
Cleared
Dec 20, 2011
I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
KHP
Acid, Lactic, Enzymatic Method
118d
Cleared
Dec 20, 2011
FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
529d
Cleared
Dec 19, 2011
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
CDD
Radioassay, Vitamin B12
117d
Cleared
Dec 15, 2011
FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
129d
Cleared
Dec 14, 2011
HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE
CHH
Enzymatic Esterase--oxidase, Cholesterol
175d
Cleared
Dec 09, 2011
PRESAGE ST2 ASSAY
OYG
St2 Assay
198d
Cleared
Dec 07, 2011
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D
NBW
System, Test, Blood Glucose, Over The Counter
370d
Cleared
Dec 06, 2011
PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
JXN
Enzyme Immunoassay, Propoxyphene
204d
Cleared
Dec 02, 2011
MAGNESIUM ASSAY
JGJ
Photometric Method, Magnesium
149d
Cleared
Dec 02, 2011
ESENSOR WARFARIN SENSITIVITY SALIVA TEST
NSU
Instrumentation For Clinical Multiplex Test Systems
255d
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