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
11227 Chemistry devices
Cleared
Dec 19, 1997
MIDSTREAM HOME REGNANCY TEST
DHA
System, Test, Human Chorionic Gonadotropin
73d
Cleared
Dec 18, 1997
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
CHH
Enzymatic Esterase--oxidase, Cholesterol
107d
Cleared
Dec 17, 1997
VIGIL LIPID CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
22d
Cleared
Dec 17, 1997
ELECSYS CK-MB STAT
JHY
Colorimetric Method, Cpk Or Isoenzymes
23d
Cleared
Dec 17, 1997
IL TEST UREA NITROGEN
CDQ
Urease And Glutamic Dehydrogenase, Urea Nitrogen
29d
Cleared
Dec 17, 1997
IL TEST AMYLASE
JFJ
Catalytic Methods, Amylase
44d
Cleared
Dec 17, 1997
DBEST ONE-STEP HCG SERUM/URINE TEST
JHI
Visual, Pregnancy Hcg, Prescription Use
62d
Cleared
Dec 17, 1997
LACTEST I
KHP
Acid, Lactic, Enzymatic Method
204d
Cleared
Dec 16, 1997
PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
81d
Cleared
Dec 16, 1997
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK
CGA
Glucose Oxidase, Glucose
168d
Cleared
Dec 15, 1997
BECKMAN CALIBRATOR 2 (CAL2)
JIX
Calibrator, Multi-analyte Mixture
61d
Cleared
Dec 15, 1997
ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
80d
Cleared
Dec 15, 1997
DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
80d
Cleared
Dec 15, 1997
ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS
LFR
Glucose Dehydrogenase, Glucose
81d
Cleared
Dec 11, 1997
URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
KQP
Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase
322d
Cleared
Dec 10, 1997
TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL
JJT
Enzyme Controls (assayed And Unassayed)
15d
Cleared
Dec 08, 1997
ELECSYS CALCHECK FOLATE
JJY
Multi-analyte Controls, All Kinds (assayed)
17d
Cleared
Dec 08, 1997
ELECSYS CALCHECK VITAMIN B12
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
17d
Cleared
Dec 08, 1997
CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN
DDR
Myoglobin, Antigen, Antiserum, Control
20d
Cleared
Dec 08, 1997
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
JFJ
Catalytic Methods, Amylase
42d
Cleared
Dec 08, 1997
RANDOX BILIRUBIN
GIG
Hemoglobinometer
48d
Cleared
Dec 05, 1997
ACCUWELL PHENYLALANINE ASSAY
JNB
Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine
42d
Cleared
Dec 05, 1997
ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30
CKA
Nadh Oxidation/nad Reduction, Alt/sgpt
45d
Cleared
Dec 05, 1997
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
MMI
Immunoassay Method, Troponin Subunit
73d
Cleared
Dec 03, 1997
SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
CGZ
Electrode, Ion-specific, Chloride
63d
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