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
11206 Chemistry devices
Cleared
Oct 12, 2005
AUTOCHECK6+
JJY
Multi-analyte Controls, All Kinds (assayed)
86d
Cleared
Oct 11, 2005
ADVIA IMS GLUCOSE ASSAY
CFR
Hexokinase, Glucose
63d
Cleared
Oct 07, 2005
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
JGS
Electrode, Ion Specific, Sodium
108d
Cleared
Oct 07, 2005
GLUCODR SUPERSENSOR SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
171d
Cleared
Oct 06, 2005
LEADCARE II BLOOD LEAD TESTING SYSTEM
DOF
Lead, Atomic Absorption
20d
Cleared
Oct 04, 2005
HBA1C LINEARITY SET
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
71d
Cleared
Oct 04, 2005
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
NBW
System, Test, Blood Glucose, Over The Counter
118d
Cleared
Oct 03, 2005
IBL CORTISOL LIA TEST KIT
CGR
Radioimmunoassay, Cortisol
38d
Cleared
Oct 03, 2005
ADVIA CHEMISTRY MICROALBUMIN CONTROLS
JJW
Urinalysis Controls (assayed And Unassayed)
47d
Cleared
Oct 03, 2005
ISE COMPENSATOR
JIT
Calibrator, Secondary
53d
Cleared
Oct 03, 2005
TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE)
CHQ
Chromatographic/fluorometric Method, Catecholamines
75d
Cleared
Sep 30, 2005
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
LCP
Assay, Glycosylated Hemoglobin
22d
Cleared
Sep 29, 2005
OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200
CGZ
Electrode, Ion-specific, Chloride
64d
Cleared
Sep 23, 2005
DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM
JJY
Multi-analyte Controls, All Kinds (assayed)
56d
Cleared
Sep 22, 2005
TRIAGE BNP TEST, MODEL 98000XR
NBC
Test, Natriuretic Peptide
83d
Cleared
Sep 09, 2005
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
CEW
Radioimmunoassay, Parathyroid Hormone
66d
Cleared
Sep 08, 2005
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK
JHX
Fluorometric Method, Cpk Or Isoenzymes
79d
Cleared
Sep 08, 2005
ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK
NEO
System, Test, Osteocalcin
113d
Cleared
Sep 02, 2005
MODIFICATION TO ACCU-CHEK GO SYSTEM
LFR
Glucose Dehydrogenase, Glucose
79d
Cleared
Sep 01, 2005
IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT
JTO
Discs, Strips And Reagents, Microorganism Differentiation
202d
Cleared
Aug 26, 2005
C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
KRZ
Calibrator For Hemoglobin And Hematocrit Measurement
23d
Cleared
Aug 25, 2005
ULTRA HDL
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
37d
Cleared
Aug 25, 2005
SENTINEL IRON LIQUID
JIY
Photometric Method, Iron (non-heme)
115d
Cleared
Aug 23, 2005
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE
CHH
Enzymatic Esterase--oxidase, Cholesterol
89d
Cleared
Aug 22, 2005
IRON STANDARD
JIT
Calibrator, Secondary
28d
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