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
11205 Chemistry devices
Cleared
Jan 13, 2006
VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET
JJY
Multi-analyte Controls, All Kinds (assayed)
53d
Cleared
Jan 13, 2006
RANDOX CALIBRATION SERUM
JIX
Calibrator, Multi-analyte Mixture
64d
Cleared
Jan 13, 2006
Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
JGS
Electrode, Ion Specific, Sodium
70d
Cleared
Jan 04, 2006
FASTPACK TSH IMMUNOASSAY
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
135d
Cleared
Dec 30, 2005
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
JFM
Enzymatic Method, Bilirubin
52d
Cleared
Dec 30, 2005
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
JFM
Enzymatic Method, Bilirubin
52d
Cleared
Dec 30, 2005
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
MMI
Immunoassay Method, Troponin Subunit
65d
Cleared
Dec 29, 2005
FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
DKZ
Enzyme Immunoassay, Amphetamine
147d
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 23, 2005
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
JMO
Ferrozine (colorimetric) Iron Binding Capacity
73d
Cleared
Dec 16, 2005
ARCHITECT B12 CALIBRATORS
JIT
Calibrator, Secondary
15d
Cleared
Dec 16, 2005
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)
NJV
Test, Albumin Cobalt Binding
30d
Cleared
Dec 16, 2005
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
JFM
Enzymatic Method, Bilirubin
44d
Cleared
Dec 16, 2005
ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
JHI
Visual, Pregnancy Hcg, Prescription Use
79d
Cleared
Dec 16, 2005
ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
CFR
Hexokinase, Glucose
144d
Cleared
Dec 15, 2005
I-STAT CREATINE KINASE MB (CK-MB)
MYT
Biosensor, Immunoassay, Cpk Or Isoenzymes
197d
Cleared
Dec 14, 2005
ISE INDIRECT NA, K, CL FOR GEN.2
JGS
Electrode, Ion Specific, Sodium
30d
Cleared
Dec 14, 2005
TECO ISE REAGENT SET FOR CX SYSTEM
JGS
Electrode, Ion Specific, Sodium
76d
Cleared
Dec 14, 2005
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
MMI
Immunoassay Method, Troponin Subunit
92d
Cleared
Dec 09, 2005
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
25d
Cleared
Dec 09, 2005
BREATHKEY MODEL G10/BREATHKEY MODEL G30X
DJZ
Devices, Breath Trapping, Alcohol
66d
Cleared
Dec 09, 2005
GLUCOSE PILOT
NBW
System, Test, Blood Glucose, Over The Counter
119d
Cleared
Dec 07, 2005
E-SAN BLUETOOTH CRADLE
NBW
System, Test, Blood Glucose, Over The Counter
103d
Cleared
Dec 07, 2005
SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
NBW
System, Test, Blood Glucose, Over The Counter
126d
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