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.
13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
Cleared
May 27, 2009
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210
CDD
Radioassay, Vitamin B12
84d
Cleared
May 22, 2009
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
JFY
Enzymatic Method, Creatinine
101d
Cleared
May 14, 2009
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
LCP
Assay, Glycosylated Hemoglobin
85d
Cleared
May 14, 2009
TEARLAB OSMOLARITY SYSTEM
OND
Osmolality Of Tears
198d
Cleared
May 12, 2009
FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
NBW
System, Test, Blood Glucose, Over The Counter
106d
Cleared
May 08, 2009
ADVIA CENTAUR TSH3-ULTRA METHOD
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
135d
Cleared
May 01, 2009
GLUCODR AUTO SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
144d
Cleared
Apr 24, 2009
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
88d
Cleared
Apr 21, 2009
CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
JJY
Multi-analyte Controls, All Kinds (assayed)
141d
Cleared
Apr 21, 2009
ONE STEP HCG URINE/SERUM TEST
DHA
System, Test, Human Chorionic Gonadotropin
594d
Cleared
Apr 16, 2009
ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
17d
Cleared
Apr 16, 2009
VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402
JJY
Multi-analyte Controls, All Kinds (assayed)
51d
Cleared
Apr 16, 2009
RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01
LFR
Glucose Dehydrogenase, Glucose
164d
Cleared
Apr 16, 2009
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
JLX
Radioimmunoassay, 17-hydroxyprogesterone
283d
Cleared
Apr 09, 2009
AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9
CGA
Glucose Oxidase, Glucose
92d
Cleared
Apr 08, 2009
ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
90d
Cleared
Apr 08, 2009
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
DCF
Albumin, Antigen, Antiserum, Control
243d
Cleared
Apr 07, 2009
CREATININE
CGX
Alkaline Picrate, Colorimetry, Creatinine
106d
Cleared
Apr 02, 2009
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
CJY
Azo Dye, Calcium
136d
Cleared
Mar 27, 2009
TRUEBALANCE BLOOD GLUCOSE SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
30d
Cleared
Mar 26, 2009
FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247
NBW
System, Test, Blood Glucose, Over The Counter
27d
Cleared
Mar 24, 2009
BETACHEK GLUCOSE TEST
NBW
System, Test, Blood Glucose, Over The Counter
966d
Cleared
Mar 23, 2009
VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
JJY
Multi-analyte Controls, All Kinds (assayed)
84d
Cleared
Mar 20, 2009
AVIE A1C TEST SYSTEM
LCP
Assay, Glycosylated Hemoglobin
319d
Cleared
Mar 13, 2009
SYMCARE DIABETES MANAGEMENT PROGRAM
NBW
System, Test, Blood Glucose, Over The Counter
128d
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