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 24, 2013
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
CIB
Radioimmunoassay, Angiotensin I And Renin
382d
Cleared
Dec 20, 2013
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
318d
Cleared
Dec 20, 2013
GENPRIME DRUGS OF ABUSE READER SYSTEM
DKZ
Enzyme Immunoassay, Amphetamine
340d
Cleared
Dec 19, 2013
SMARTLOG DIABETES MANAGEMENT SOFTWARE
NBW
System, Test, Blood Glucose, Over The Counter
50d
Cleared
Dec 19, 2013
LP(A) CALIBRATORS, AND LP(A) CONTROLS
JIT
Calibrator, Secondary
140d
Cleared
Dec 19, 2013
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
167d
Cleared
Dec 18, 2013
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
JGS
Electrode, Ion Specific, Sodium
138d
Cleared
Dec 12, 2013
HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
91d
Cleared
Dec 05, 2013
GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
76d
Cleared
Dec 04, 2013
ELECSYS CALCITONIN
JKR
Radioimmunoassay, Calcitonin
86d
Cleared
Nov 26, 2013
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
JIX
Calibrator, Multi-analyte Mixture
25d
Cleared
Nov 26, 2013
PRODIGY CHOICE
NBW
System, Test, Blood Glucose, Over The Counter
481d
Cleared
Nov 22, 2013
ELECSYS CK-MB CALCHECK 5
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
28d
Cleared
Nov 22, 2013
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
CDT
Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
56d
Cleared
Nov 22, 2013
CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER
NBW
System, Test, Blood Glucose, Over The Counter
122d
Cleared
Nov 22, 2013
GLB BENECHECK PREMIUM GLU MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
417d
Cleared
Nov 21, 2013
INFLAMMA DRY
PFQ
Mmp-9 Test System
141d
Cleared
Nov 21, 2013
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
CGS
Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
330d
Cleared
Nov 20, 2013
AGAMATRIX HEALTH MANAGER
NBW
System, Test, Blood Glucose, Over The Counter
72d
Not Cleared
Nov 19, 2013
MISEQDX UNIVERSAL KIT 1.0
PFT
Reagents For Molecular Diagnostic Test Systems
46d
Not Cleared
Nov 19, 2013
ILLUMINA MISEQDX PLATFORM
PFF
High Throughput Dna Sequence Analyzer
57d
Cleared
Nov 14, 2013
GSP NEONATAL BIOTINIDASE KIT
NAK
System, Test, Biotinidase
192d
Cleared
Nov 12, 2013
ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
130d
Cleared
Nov 08, 2013
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
CEW
Radioimmunoassay, Parathyroid Hormone
88d
Cleared
Nov 07, 2013
UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
190d
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