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
11208 Chemistry devices
Cleared
Jul 14, 2004
TSH-CTK-3 IRMA
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
85d
Cleared
Jul 06, 2004
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
DIF
Drug Mixture Control Materials
26d
Cleared
Jul 06, 2004
PTS PANELS LDL CHOLESTEROL TEST STRIPS
MRR
System, Test, Low Density, Lipoprotein
111d
Cleared
Jul 06, 2004
TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS
JJY
Multi-analyte Controls, All Kinds (assayed)
134d
Cleared
Jul 02, 2004
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
CDD
Radioassay, Vitamin B12
63d
Cleared
Jun 30, 2004
RAICHEM GLUCOSE UV (LIQUID)
CFR
Hexokinase, Glucose
72d
Cleared
Jun 30, 2004
RAICHEM BUN RATE REAGENT (LIQUID)
CDQ
Urease And Glutamic Dehydrogenase, Urea Nitrogen
72d
Cleared
Jun 25, 2004
RAICHEM CALCIUM (OCPC) LIQUID REAGENT
CIC
Cresolphthalein Complexone, Calcium
67d
Cleared
Jun 25, 2004
TRIAGE PROFILER S.O.B. PANEL
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
127d
Cleared
Jun 25, 2004
N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
DCK
C-reactive Protein, Antigen, Antiserum, And Control
143d
Cleared
Jun 18, 2004
TAIDOC CHECK
NBW
System, Test, Blood Glucose, Over The Counter
51d
Cleared
Jun 18, 2004
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
DCK
C-reactive Protein, Antigen, Antiserum, And Control
106d
Cleared
Jun 17, 2004
FSH MENOPAUSE PREDICTOR TEST
CGJ
Radioimmunoassay, Follicle-stimulating Hormone
44d
Cleared
Jun 16, 2004
RANDOX IMMUNOASSAY CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
120d
Cleared
Jun 16, 2004
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
JJF
Analyzer, Chemistry, Micro, For Clinical Use
127d
Cleared
Jun 14, 2004
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
NBC
Test, Natriuretic Peptide
117d
Cleared
Jun 09, 2004
BIO-RAD D-10 DUAL PROGRAM
LCP
Assay, Glycosylated Hemoglobin
8d
Cleared
Jun 09, 2004
RANDOX AMIKACIN
KLQ
Radioimmunoassay, Amikacin
177d
Cleared
Jun 08, 2004
CLEARBLUE EASY EASY READ PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
13d
Cleared
Jun 08, 2004
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
CEW
Radioimmunoassay, Parathyroid Hormone
70d
Cleared
Jun 07, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
74d
Cleared
Jun 02, 2004
TOTAL BILIRUBIN REAGENT SET
CIG
Diazo Colorimetry, Bilirubin
106d
Cleared
May 28, 2004
VENOJECT LUER ADAPTER
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
7d
Cleared
May 27, 2004
MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
JJY
Multi-analyte Controls, All Kinds (assayed)
17d
Cleared
May 21, 2004
DOCUMENT SALICYLATE CAL VER
JJY
Multi-analyte Controls, All Kinds (assayed)
25d
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