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
191d
Avg (2y)
1976
Since
11180 Chemistry devices
Cleared
Aug 01, 2014
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
198d
Cleared
Jul 28, 2014
ACE CALIBRATOR
JIT
Calibrator, Secondary
32d
Cleared
Jul 24, 2014
HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
LCP
Assay, Glycosylated Hemoglobin
24d
Cleared
Jul 24, 2014
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY
MRG
System, Test, Vitamin D
280d
Cleared
Jul 18, 2014
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
JHW
U.v. Method, Cpk Isoenzymes
64d
Cleared
Jul 17, 2014
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
28d
Cleared
Jul 17, 2014
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
NDY
Test, Cystatin C
76d
Cleared
Jul 14, 2014
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
LCP
Assay, Glycosylated Hemoglobin
104d
Cleared
Jul 11, 2014
SYSTEM CALIBRATER
JIX
Calibrator, Multi-analyte Mixture
45d
Cleared
Jul 11, 2014
ABX PENTRA MICRO ALB CONTROL L/H
JJY
Multi-analyte Controls, All Kinds (assayed)
224d
Cleared
Jul 09, 2014
IMMULITE 2000
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
37d
Cleared
Jul 03, 2014
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
162d
Cleared
Jun 30, 2014
BICARBONATE CALIBRATOR
JIT
Calibrator, Secondary
34d
Cleared
Jun 30, 2014
ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM
CGA
Glucose Oxidase, Glucose
550d
Cleared
Jun 27, 2014
MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
247d
Cleared
Jun 25, 2014
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
LCP
Assay, Glycosylated Hemoglobin
86d
Cleared
Jun 25, 2014
IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
345d
Cleared
Jun 23, 2014
CONTOUR NEXT EZ BLOOD GLUCOSE METER
NBW
System, Test, Blood Glucose, Over The Counter
504d
Cleared
Jun 06, 2014
HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST
LDJ
Enzyme Immunoassay, Cannabinoids
94d
Cleared
May 29, 2014
URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
JIL
Method, Enzymatic, Glucose (urinary, Non-quantitative)
360d
Cleared
May 22, 2014
RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
79d
Cleared
May 22, 2014
ISE INDIRECT NA, K, C1 FOR GEN 2
JGS
Electrode, Ion Specific, Sodium
97d
Cleared
May 22, 2014
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
164d
Cleared
May 16, 2014
CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
182d
Cleared
May 15, 2014
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
408d
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