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.
13234
Total
13203
Cleared
199d
Avg (2y)
1976
Since
8200 Chemistry devices
Cleared
Mar 15, 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
56d
Cleared
Mar 07, 2013
DIMENSION VISTA
JIF
Enzymatic Method, Ammonia
97d
Cleared
Mar 01, 2013
LIQUID ASSAYED MULTIQUAL PREMIUM
JJY
Multi-analyte Controls, All Kinds (assayed)
37d
Cleared
Mar 01, 2013
EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
CIG
Diazo Colorimetry, Bilirubin
81d
Cleared
Feb 28, 2013
COBAS INTEGRA BILIRUBIN DIRECT GEN.2
CIG
Diazo Colorimetry, Bilirubin
64d
Cleared
Feb 15, 2013
DIMENSION CHEMISTRY III CALIBRATORY
JIX
Calibrator, Multi-analyte Mixture
112d
Cleared
Feb 15, 2013
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
JIF
Enzymatic Method, Ammonia
112d
Cleared
Feb 15, 2013
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
MRG
System, Test, Vitamin D
259d
Cleared
Feb 14, 2013
GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
62d
Cleared
Feb 12, 2013
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
434d
Cleared
Feb 07, 2013
ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
NBW
System, Test, Blood Glucose, Over The Counter
349d
Cleared
Feb 01, 2013
ARCHITECT TOTAL BILIRUBIN
CIG
Diazo Colorimetry, Bilirubin
210d
Cleared
Jan 31, 2013
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK
JJY
Multi-analyte Controls, All Kinds (assayed)
52d
Cleared
Jan 25, 2013
GLUCOSE METER-CHECK SOLUTION FOR BAYER
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
30d
Cleared
Jan 25, 2013
LIAISON TESTOSTERONE
CDZ
Radioimmunoassay, Testosterones And Dihydrotestosterone
135d
Cleared
Jan 17, 2013
FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
55d
Cleared
Jan 14, 2013
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
JIX
Calibrator, Multi-analyte Mixture
74d
Cleared
Jan 09, 2013
LIQUIDCHEK DIABETES CONTROL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
30d
Cleared
Jan 01, 2013
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
CIB
Radioimmunoassay, Angiotensin I And Renin
182d
Cleared
Dec 27, 2012
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT
JJY
Multi-analyte Controls, All Kinds (assayed)
29d
Cleared
Dec 27, 2012
QUICK SAMPLER HOLDER
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
314d
Cleared
Dec 21, 2012
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
DKZ
Enzyme Immunoassay, Amphetamine
87d
Cleared
Dec 20, 2012
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
83d
Cleared
Dec 20, 2012
NOVA ONE BLOOD GLUCOSE MONITOR
LFR
Glucose Dehydrogenase, Glucose
132d
Cleared
Dec 14, 2012
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
78d
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