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
11204 Chemistry devices
Cleared
Jun 13, 2006
THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
NBW
System, Test, Blood Glucose, Over The Counter
32d
Cleared
Jun 13, 2006
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR
LPS
Urinary Homocystine (nonquantitative) Test System
35d
Cleared
Jun 13, 2006
ICHEM 100 URINE CHEMISTRY ANALYZER
JIL
Method, Enzymatic, Glucose (urinary, Non-quantitative)
131d
Cleared
Jun 06, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158
NBC
Test, Natriuretic Peptide
89d
Cleared
Jun 06, 2006
ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST
DJC
Thin Layer Chromatography, Methamphetamine
222d
Cleared
Jun 05, 2006
GLUCOPACK
NBW
System, Test, Blood Glucose, Over The Counter
270d
Cleared
Jun 02, 2006
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
JIT
Calibrator, Secondary
25d
Cleared
Jun 02, 2006
CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250
DXN
System, Measurement, Blood-pressure, Non-invasive
46d
Cleared
May 31, 2006
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
JIS
Calibrator, Primary
27d
Cleared
May 30, 2006
CARDIOIMMUNE XL CARDIAC MARKER CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
32d
Cleared
May 30, 2006
NOD CHEMISTRY CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
63d
Cleared
May 25, 2006
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
KHS
Enzymatic, Carbon-dioxide
22d
Cleared
May 25, 2006
CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2
JJY
Multi-analyte Controls, All Kinds (assayed)
28d
Cleared
May 25, 2006
ARCHITECT BNP ASSAY, MODEL 8K28
NBC
Test, Natriuretic Peptide
48d
Cleared
May 25, 2006
CLEARBLUE EASY DIGITAL PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
127d
Cleared
May 25, 2006
PURE-AID PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
164d
Cleared
May 19, 2006
ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
28d
Cleared
May 19, 2006
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
DKZ
Enzyme Immunoassay, Amphetamine
169d
Cleared
May 17, 2006
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
CFR
Hexokinase, Glucose
30d
Cleared
May 15, 2006
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
DQD
Stethoscope, Electronic
95d
Cleared
May 10, 2006
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
CKA
Nadh Oxidation/nad Reduction, Alt/sgpt
27d
Cleared
May 05, 2006
GLUCOSE
CFR
Hexokinase, Glucose
80d
Cleared
May 04, 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
NQD
Cardiac C-reactive Protein, Antigen, Antiserum, And Control
80d
Cleared
May 04, 2006
CARBON DIOXIDE
KHS
Enzymatic, Carbon-dioxide
87d
Cleared
May 03, 2006
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
CKG
Radioimmunoassay, Acth
57d
Looking for a specific chemistry device? Search by device name, K-number or manufacturer.
Search all Chemistry 510(k) devices