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
11233 Chemistry devices
Cleared
May 30, 1996
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
CEK
Biuret (colorimetric), Total Protein
153d
Cleared
May 30, 1996
UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE
CDP
Radioimmunoassay, Total Triiodothyronine
62d
Cleared
May 30, 1996
GASTRIN EIA MODEL 06B-555017
CGC
Radioimmunoassay, Gastrin
57d
Cleared
May 24, 1996
EKTACHEM DT LDL CHOLESTEROL KIT
MRR
System, Test, Low Density, Lipoprotein
147d
Cleared
May 23, 1996
BUHLMANN VITAMIN B6 REA
CDD
Radioassay, Vitamin B12
169d
Cleared
May 23, 1996
AST INCORPORATING DST
CIT
Nadh Oxidation/nad Reduction, Ast/sgot
64d
Cleared
May 17, 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)
CGA
Glucose Oxidase, Glucose
183d
Cleared
May 15, 1996
ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
CGI
Radioimmunoassay, Estriol
176d
Cleared
May 15, 1996
CHEM-CHEX STAT
JJY
Multi-analyte Controls, All Kinds (assayed)
49d
Cleared
May 15, 1996
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
CDN
Urease, Photometric, Urea Nitrogen
49d
Cleared
May 14, 1996
AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE
KQO
Automated Urinalysis System
403d
Cleared
May 13, 1996
ELECTROLYTE STANDARDS
JJR
Electrolyte Controls (assayed And Unassayed)
91d
Cleared
May 10, 1996
SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
JMO
Ferrozine (colorimetric) Iron Binding Capacity
98d
Cleared
May 07, 1996
DSL ACTIVE I-HCG IRMA
JHI
Visual, Pregnancy Hcg, Prescription Use
103d
Cleared
May 07, 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)
JGS
Electrode, Ion Specific, Sodium
49d
Cleared
May 07, 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)
CEM
Electrode, Ion Specific, Potassium
48d
Cleared
May 07, 1996
EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE
CJY
Azo Dye, Calcium
39d
Cleared
May 06, 1996
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)
JKR
Radioimmunoassay, Calcitonin
53d
Cleared
May 02, 1996
KETOREX C SANWA
JMK
Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase
289d
Cleared
May 02, 1996
ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT
DHA
System, Test, Human Chorionic Gonadotropin
139d
Cleared
May 02, 1996
ENA-C-T TOTAL CHOLESTEROL TEST
CHH
Enzymatic Esterase--oxidase, Cholesterol
97d
Cleared
May 02, 1996
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2
JJY
Multi-analyte Controls, All Kinds (assayed)
28d
Cleared
May 01, 1996
MINISTICK PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
69d
Cleared
Apr 30, 1996
STC DIAGNOSTICS AUTO-LYTE PH ASSAY
KQO
Automated Urinalysis System
238d
Cleared
Apr 30, 1996
TONOMETERED SLAINE BLOOD GAS CONTROL
JJS
Controls For Blood-gases, (assayed And Unassayed)
15d
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