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.
13224
Total
13193
Cleared
208d
Avg (2y)
1976
Since
3201 Chemistry devices
Cleared
Jan 14, 2013
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
JIX
Calibrator, Multi-analyte Mixture
74d
Cleared
Nov 27, 2012
ABBOTT ARCHITECT FREE T4
CEC
Radioimmunoassay, Free Thyroxine
26d
Cleared
Oct 12, 2012
GLYCOSYLATED HEMOGLOBIN ASSAY
LCP
Assay, Glycosylated Hemoglobin
263d
Cleared
Sep 11, 2012
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
LCP
Assay, Glycosylated Hemoglobin
113d
Cleared
Sep 11, 2012
TESTOSTERONE TEST SYSTEM
CDZ
Radioimmunoassay, Testosterones And Dihydrotestosterone
252d
Cleared
May 17, 2012
ARCHITECT B12
CDD
Radioassay, Vitamin B12
15d
Cleared
May 03, 2012
GEM PREMIER 4000
CEM
Electrode, Ion Specific, Potassium
209d
Cleared
Feb 16, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
LFR
Glucose Dehydrogenase, Glucose
230d
Cleared
Dec 23, 2011
AU5800(R) CHEMISTRY ANALYZER
CEM
Electrode, Ion Specific, Potassium
123d
Cleared
Oct 06, 2011
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
CDD
Radioassay, Vitamin B12
219d
Cleared
Aug 19, 2011
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
JIT
Calibrator, Secondary
39d
Cleared
Jun 10, 2011
ABBOTT ARCHITECT LH CALIBRATORS
JIT
Calibrator, Secondary
58d
Cleared
May 25, 2011
SYNCHRON MULTI CALIBRATOR
JIX
Calibrator, Multi-analyte Mixture
117d
Cleared
May 11, 2011
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
CDD
Radioassay, Vitamin B12
86d
Cleared
May 06, 2011
URIC ACID MODEL 3P39
KNK
Acid, Uric, Uricase (colorimetric)
241d
Cleared
Apr 27, 2011
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
CGA
Glucose Oxidase, Glucose
118d
Cleared
Feb 04, 2011
MULTICONSTITUENT CALIBRATOR
JIX
Calibrator, Multi-analyte Mixture
77d
Cleared
Sep 09, 2010
COBAS 8000 MODULAR SERIES ANALYZER
DCF
Albumin, Antigen, Antiserum, Control
167d
Cleared
Jul 28, 2010
AMPHETAMINES II ASSAY
DKZ
Enzyme Immunoassay, Amphetamine
243d
Cleared
Jun 18, 2010
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
CIG
Diazo Colorimetry, Bilirubin
207d
Cleared
Jun 11, 2010
ELECSYS INSULIN CALCHECK 5
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
53d
Cleared
May 14, 2010
HDL CHOLESTEROL (HDLX) ASSAY
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
130d
Cleared
Apr 23, 2010
ELECSYS TESTOSTERONE II IMMUNOASSAY
CDZ
Radioimmunoassay, Testosterones And Dihydrotestosterone
171d
Cleared
Mar 19, 2010
ELECSYS TROPONIN T CALCHECK 5
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
184d
Cleared
Mar 05, 2010
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74
CGN
Acid, Folic, Radioimmunoassay
178d
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