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
11207 Chemistry devices
Cleared
Nov 23, 2004
LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
MRR
System, Test, Low Density, Lipoprotein
127d
Cleared
Nov 23, 2004
HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278
JIX
Calibrator, Multi-analyte Mixture
127d
Cleared
Nov 19, 2004
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT
DDG
Transferrin, Antigen, Antiserum, Control
67d
Cleared
Nov 19, 2004
MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD
NBC
Test, Natriuretic Peptide
81d
Cleared
Nov 19, 2004
INSTANT-VIEW TROPONIN I TEST
MMI
Immunoassay Method, Troponin Subunit
94d
Cleared
Nov 18, 2004
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II
DCF
Albumin, Antigen, Antiserum, Control
52d
Cleared
Nov 18, 2004
QUIKREAD CRP CALIBRATOR SET
JJY
Multi-analyte Controls, All Kinds (assayed)
52d
Cleared
Nov 18, 2004
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS
JIT
Calibrator, Secondary
63d
Cleared
Nov 17, 2004
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
LCP
Assay, Glycosylated Hemoglobin
68d
Cleared
Nov 16, 2004
MULTI-CHEM CALIBRATOR A
JIX
Calibrator, Multi-analyte Mixture
57d
Cleared
Nov 12, 2004
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
CEM
Electrode, Ion Specific, Potassium
80d
Cleared
Nov 08, 2004
MULTI-LIPID CALIBRATOR
JIX
Calibrator, Multi-analyte Mixture
49d
Cleared
Nov 08, 2004
MULTI CHEM CAL B
JIX
Calibrator, Multi-analyte Mixture
49d
Cleared
Nov 05, 2004
MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
36d
Cleared
Nov 03, 2004
ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
JIT
Calibrator, Secondary
70d
Cleared
Nov 02, 2004
LIQUICHEK ELEVATED CRP CONTROL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
19d
Cleared
Nov 02, 2004
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
JJW
Urinalysis Controls (assayed And Unassayed)
54d
Cleared
Oct 29, 2004
TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
NQD
Cardiac C-reactive Protein, Antigen, Antiserum, And Control
46d
Cleared
Oct 29, 2004
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
50d
Cleared
Oct 29, 2004
DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT
LCP
Assay, Glycosylated Hemoglobin
78d
Cleared
Oct 29, 2004
DIAZYME POTASSIUM ENZYMATIC ASSAY KIT
MZV
Test, System, Potassium, Enzymatic Method
78d
Cleared
Oct 29, 2004
HDL-EX SEIKEN ASSAY KIT
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
186d
Cleared
Oct 28, 2004
VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
94d
Cleared
Oct 28, 2004
BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR
CGA
Glucose Oxidase, Glucose
147d
Cleared
Oct 27, 2004
GLUCOSE TOLERANCE BEVERAGE
MRV
Drink, Glucose Tolerance
77d
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