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
11217 Chemistry devices
Cleared
Jul 02, 2001
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
CEW
Radioimmunoassay, Parathyroid Hormone
47d
Cleared
Jun 25, 2001
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
CIX
Bromcresol Green Dye-binding, Albumin
21d
Cleared
Jun 25, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS
JIX
Calibrator, Multi-analyte Mixture
66d
Cleared
Jun 25, 2001
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
JFJ
Catalytic Methods, Amylase
91d
Cleared
Jun 20, 2001
ACCU-CHEK ACTIVE SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
15d
Cleared
Jun 20, 2001
BIOSCANNER CREATININE TEST STRIPS
JFY
Enzymatic Method, Creatinine
124d
Cleared
Jun 18, 2001
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3
JJY
Multi-analyte Controls, All Kinds (assayed)
31d
Cleared
Jun 18, 2001
PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY
NBW
System, Test, Blood Glucose, Over The Counter
112d
Cleared
Jun 14, 2001
DIMENSION DRUG CALIBRATOR, MODEL DC22B
JIX
Calibrator, Multi-analyte Mixture
70d
Cleared
Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
30d
Cleared
Jun 13, 2001
HYDRAGEL ISO-PAL K20 (PN 3022)
CIN
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
63d
Cleared
Jun 08, 2001
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
LDP
Colorimetry, Acetaminophen
25d
Cleared
Jun 07, 2001
DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
JIH
Flame Photometry, Lithium
63d
Cleared
Jun 06, 2001
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
DLZ
Enzyme Immunoassay, Phenobarbital
20d
Cleared
Jun 05, 2001
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
MMI
Immunoassay Method, Troponin Subunit
112d
Cleared
May 29, 2001
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
DCK
C-reactive Protein, Antigen, Antiserum, And Control
90d
Cleared
May 23, 2001
CHEMWELL, MODEL 2900
CIX
Bromcresol Green Dye-binding, Albumin
61d
Cleared
May 21, 2001
ANALYST PANELS + ANALYTICAL TEST ROTOR
KHS
Enzymatic, Carbon-dioxide
60d
Cleared
May 18, 2001
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
CGA
Glucose Oxidase, Glucose
25d
Cleared
May 16, 2001
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
JGS
Electrode, Ion Specific, Sodium
26d
Cleared
May 10, 2001
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
KLS
Enzyme Immunoassay, Theophylline
24d
Cleared
May 10, 2001
MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
JXN
Enzyme Immunoassay, Propoxyphene
24d
Cleared
May 08, 2001
RANDOX MYOGLOBIN
DDR
Myoglobin, Antigen, Antiserum, Control
61d
Cleared
May 07, 2001
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
CGA
Glucose Oxidase, Glucose
74d
Cleared
May 02, 2001
RAICHEM CREATININE URINE STANDARD
JIT
Calibrator, Secondary
19d
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