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
11215 Chemistry devices
Cleared
Jun 04, 2002
PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
JGS
Electrode, Ion Specific, Sodium
120d
Cleared
Jun 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
28d
Cleared
Jun 03, 2002
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
CKG
Radioimmunoassay, Acth
66d
Cleared
May 31, 2002
AXSYM INTACT PTH, MODEL 2G06
CEW
Radioimmunoassay, Parathyroid Hormone
67d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469
DIF
Drug Mixture Control Materials
26d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467
DIF
Drug Mixture Control Materials
26d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
DIF
Drug Mixture Control Materials
26d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
DIF
Drug Mixture Control Materials
27d
Cleared
May 24, 2002
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
JJT
Enzyme Controls (assayed And Unassayed)
15d
Cleared
May 23, 2002
STATUS HCG SERUM/URINE
JHI
Visual, Pregnancy Hcg, Prescription Use
101d
Cleared
May 17, 2002
QUICKVUE ONE-STEP HCG-COMBO
JHI
Visual, Pregnancy Hcg, Prescription Use
66d
Cleared
May 17, 2002
QUICKVUE ONE-STEP HCG-URINE
JHI
Visual, Pregnancy Hcg, Prescription Use
66d
Cleared
May 14, 2002
IRON-PC-SL ASSAY MODEL # 151-10, 151-26
JIY
Photometric Method, Iron (non-heme)
62d
Cleared
May 10, 2002
OCTEIA 25-HYDROXY VITAMIN D
MRG
System, Test, Vitamin D
29d
Cleared
May 09, 2002
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
MRR
System, Test, Low Density, Lipoprotein
64d
Cleared
May 08, 2002
DIMENSION ALDL CALIBRATOR, MODEL DC131
JIT
Calibrator, Secondary
63d
Cleared
May 06, 2002
SPIFE 2000/3000 ALP 40, 20
CIN
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
69d
Cleared
Apr 29, 2002
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
JJW
Urinalysis Controls (assayed And Unassayed)
19d
Cleared
Apr 22, 2002
LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
DIE
Heavy Metals Control Materials
56d
Cleared
Apr 15, 2002
CARESIDE TRGLYCERIDE
CDT
Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
61d
Cleared
Apr 12, 2002
LIQUICHEK URINE CHEMISTRY CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
30d
Cleared
Apr 12, 2002
MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS
MMI
Immunoassay Method, Troponin Subunit
42d
Cleared
Apr 08, 2002
CHEMISTRY CALIBRATOR
JIT
Calibrator, Secondary
56d
Cleared
Apr 05, 2002
FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300
CEC
Radioimmunoassay, Free Thyroxine
45d
Cleared
Mar 29, 2002
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
CFE
Electrophoretic, Lactate Dehydrogenase Isoenzymes
45d
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