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 16, 2005
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)
NJV
Test, Albumin Cobalt Binding
30d
Cleared
Dec 16, 2005
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
JFM
Enzymatic Method, Bilirubin
44d
Cleared
Dec 16, 2005
ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
JHI
Visual, Pregnancy Hcg, Prescription Use
79d
Cleared
Dec 16, 2005
ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
CFR
Hexokinase, Glucose
144d
Cleared
Dec 15, 2005
I-STAT CREATINE KINASE MB (CK-MB)
MYT
Biosensor, Immunoassay, Cpk Or Isoenzymes
197d
Cleared
Dec 14, 2005
ISE INDIRECT NA, K, CL FOR GEN.2
JGS
Electrode, Ion Specific, Sodium
30d
Cleared
Dec 14, 2005
TECO ISE REAGENT SET FOR CX SYSTEM
JGS
Electrode, Ion Specific, Sodium
76d
Cleared
Dec 14, 2005
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
MMI
Immunoassay Method, Troponin Subunit
92d
Cleared
Dec 09, 2005
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
25d
Cleared
Dec 09, 2005
BREATHKEY MODEL G10/BREATHKEY MODEL G30X
DJZ
Devices, Breath Trapping, Alcohol
66d
Cleared
Dec 09, 2005
GLUCOSE PILOT
NBW
System, Test, Blood Glucose, Over The Counter
119d
Cleared
Dec 07, 2005
E-SAN BLUETOOTH CRADLE
NBW
System, Test, Blood Glucose, Over The Counter
103d
Cleared
Dec 07, 2005
SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
NBW
System, Test, Blood Glucose, Over The Counter
126d
Cleared
Dec 07, 2005
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
NHG
Enzyme Immunoassay, Cortisol, Salivary
162d
Cleared
Dec 07, 2005
TOTAL BILE ACIDS ASSAY, MODEL DZ042A
KWW
Radioimmunoassay, Cholyglycine, Bile Acids
163d
Cleared
Dec 05, 2005
ELECSYS PROBNP IMMUNOASSAY
NBC
Test, Natriuretic Peptide
192d
Cleared
Nov 30, 2005
LIBERTY GLUCOSE CONTROL, MODEL 2120031
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
37d
Cleared
Nov 30, 2005
ONE STEP FSH MENOPAUSAL TEST
CGJ
Radioimmunoassay, Follicle-stimulating Hormone
64d
Cleared
Nov 29, 2005
CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN
MMI
Immunoassay Method, Troponin Subunit
134d
Cleared
Nov 28, 2005
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
28d
Cleared
Nov 25, 2005
SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
JIF
Enzymatic Method, Ammonia
207d
Cleared
Nov 23, 2005
BE-CERTAIN PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
127d
Cleared
Nov 22, 2005
URYXXON 200 URINE ANALYZER
JIL
Method, Enzymatic, Glucose (urinary, Non-quantitative)
214d
Cleared
Nov 18, 2005
CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
51d
Cleared
Nov 18, 2005
QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
NWM
Immunoassay, Anti-seizure Drug
191d
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