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
Dec 04, 2009
DIDGET BLOOD GLUCOSE METER, MODEL 6181
NBW
System, Test, Blood Glucose, Over The Counter
270d
Cleared
Dec 01, 2009
LIPIDPRO SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
285d
Cleared
Nov 24, 2009
ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM
CGA
Glucose Oxidase, Glucose
133d
Cleared
Nov 20, 2009
ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
53d
Cleared
Nov 20, 2009
FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
CGA
Glucose Oxidase, Glucose
155d
Cleared
Nov 19, 2009
MICRODOT XTRA
NBW
System, Test, Blood Glucose, Over The Counter
378d
Cleared
Nov 17, 2009
EASYRA MG REAGENT, MODEL 10220
JGJ
Photometric Method, Magnesium
70d
Cleared
Nov 17, 2009
GLUCO LAB AUTO CODING, MODEL IGM-0022
NBW
System, Test, Blood Glucose, Over The Counter
210d
Cleared
Nov 16, 2009
ELECSYS HCG+B CALCHECK 5
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
118d
Cleared
Nov 16, 2009
SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268
NBW
System, Test, Blood Glucose, Over The Counter
151d
Cleared
Nov 13, 2009
TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
JJY
Multi-analyte Controls, All Kinds (assayed)
45d
Cleared
Nov 06, 2009
OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
129d
Cleared
Nov 03, 2009
ELECSYS PRECICONTROL THYROAB
JJY
Multi-analyte Controls, All Kinds (assayed)
91d
Cleared
Oct 26, 2009
S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)
CHH
Enzymatic Esterase--oxidase, Cholesterol
166d
Cleared
Oct 23, 2009
ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS
CGA
Glucose Oxidase, Glucose
190d
Cleared
Oct 21, 2009
EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009
NBW
System, Test, Blood Glucose, Over The Counter
30d
Cleared
Oct 20, 2009
POLY-CHEM 90 GLUCOSE
CFR
Hexokinase, Glucose
217d
Cleared
Oct 16, 2009
ABX PENTRA TPU CAL, MODEL A11A01898
JIT
Calibrator, Secondary
56d
Cleared
Oct 16, 2009
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
JFJ
Catalytic Methods, Amylase
116d
Cleared
Oct 16, 2009
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
DDR
Myoglobin, Antigen, Antiserum, Control
345d
Cleared
Oct 09, 2009
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
JIL
Method, Enzymatic, Glucose (urinary, Non-quantitative)
165d
Cleared
Oct 09, 2009
POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
212d
Cleared
Oct 02, 2009
AIA-PACK RBC FOLATE
CGN
Acid, Folic, Radioimmunoassay
149d
Cleared
Oct 02, 2009
EOCENE SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
198d
Cleared
Oct 01, 2009
PICCOLO MAGNESIUM TEST SYSTEM
JGJ
Photometric Method, Magnesium
98d
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