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
May 21, 2004
VITALAB IRON REAGENT
JIY
Photometric Method, Iron (non-heme)
150d
Cleared
May 20, 2004
ONE-STEP PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
8d
Cleared
May 20, 2004
CLINICAL LABORATORY ANALYZING SYSTEM
LFR
Glucose Dehydrogenase, Glucose
10d
Cleared
May 19, 2004
PARADIGM LINK BLOOD GLUCOSE METER
NBW
System, Test, Blood Glucose, Over The Counter
75d
Cleared
May 17, 2004
LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
38d
Cleared
May 17, 2004
WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
39d
Cleared
May 17, 2004
ELECSYS TROPONIN T STAT TEST
MMI
Immunoassay Method, Troponin Subunit
56d
Cleared
May 14, 2004
BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
18d
Cleared
May 14, 2004
BILIRUBIN ASSAY ON THE OMNI S ANALYZER
MQM
Bilirubin (total And Unbound) In The Neonate Test System
109d
Cleared
May 10, 2004
AMYLASE LIQUID REAGENT, MODEL A532-200
JFJ
Catalytic Methods, Amylase
32d
Cleared
May 07, 2004
NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
17d
Cleared
Apr 29, 2004
QUICKVUE ADVANCE PH AND AMINES GLL TEST
CEN
Dye-indicator, Ph (urinary, Non-quantitative)
118d
Cleared
Apr 28, 2004
MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
JJY
Multi-analyte Controls, All Kinds (assayed)
23d
Cleared
Apr 23, 2004
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
JIT
Calibrator, Secondary
133d
Cleared
Apr 22, 2004
ACCU-CHEK GO SYSTEM
LFR
Glucose Dehydrogenase, Glucose
24d
Cleared
Apr 22, 2004
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
CEW
Radioimmunoassay, Parathyroid Hormone
146d
Cleared
Apr 15, 2004
VARIANT II HEMOGLOBIN A1C
LCP
Assay, Glycosylated Hemoglobin
13d
Cleared
Apr 15, 2004
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
16d
Cleared
Apr 08, 2004
OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023
JIT
Calibrator, Secondary
22d
Cleared
Apr 08, 2004
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
DKZ
Enzyme Immunoassay, Amphetamine
78d
Cleared
Apr 02, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
JIX
Calibrator, Multi-analyte Mixture
58d
Cleared
Mar 29, 2004
LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS
JJY
Multi-analyte Controls, All Kinds (assayed)
27d
Cleared
Mar 25, 2004
MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL
NBW
System, Test, Blood Glucose, Over The Counter
10d
Cleared
Mar 25, 2004
PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
15d
Cleared
Mar 25, 2004
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET
JIT
Calibrator, Secondary
52d
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