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
May 04, 2007
DBEST HCG PANEL TEST KIT
JHI
Visual, Pregnancy Hcg, Prescription Use
365d
Cleared
May 02, 2007
IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)
NQD
Cardiac C-reactive Protein, Antigen, Antiserum, And Control
22d
Cleared
Apr 30, 2007
CARBON DIOXIDE LIQUID STABLE REAGENT
KHS
Enzymatic, Carbon-dioxide
94d
Cleared
Apr 30, 2007
EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
244d
Cleared
Apr 26, 2007
ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H
CIC
Cresolphthalein Complexone, Calcium
90d
Cleared
Apr 25, 2007
LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X
JJW
Urinalysis Controls (assayed And Unassayed)
28d
Cleared
Apr 23, 2007
DIAZYME CREATININE LIQUID REAGENTS ASSAY
JFY
Enzymatic Method, Creatinine
273d
Cleared
Apr 18, 2007
SMS MULTI GLUCOSE CONTROL, MODEL 2120049
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
56d
Cleared
Apr 17, 2007
ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72
LCP
Assay, Glycosylated Hemoglobin
167d
Cleared
Apr 13, 2007
MULTI-ANALYTE CHEMISTRY CALIBRATOR
JIX
Calibrator, Multi-analyte Mixture
81d
Cleared
Apr 12, 2007
SMS GLUCOSE CONTROL, MODEL 2120061
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
35d
Cleared
Apr 11, 2007
AMMONIA/ALCOHOL CONTROL SET
JJY
Multi-analyte Controls, All Kinds (assayed)
49d
Cleared
Apr 11, 2007
TECO HOMOCYSTEINE ENZYMATIC ASSAY
LPS
Urinary Homocystine (nonquantitative) Test System
119d
Cleared
Apr 10, 2007
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
13d
Cleared
Apr 09, 2007
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
LCP
Assay, Glycosylated Hemoglobin
24d
Cleared
Apr 09, 2007
ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
NBW
System, Test, Blood Glucose, Over The Counter
32d
Cleared
Apr 09, 2007
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS
DHA
System, Test, Human Chorionic Gonadotropin
115d
Cleared
Apr 06, 2007
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
KNK
Acid, Uric, Uricase (colorimetric)
193d
Cleared
Apr 06, 2007
COMBI SCAN100
JIL
Method, Enzymatic, Glucose (urinary, Non-quantitative)
284d
Cleared
Apr 06, 2007
COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
JIL
Method, Enzymatic, Glucose (urinary, Non-quantitative)
284d
Cleared
Apr 02, 2007
LYPHOCHEK DIABETES CONTROL
GGM
Control, Hemoglobin
35d
Cleared
Mar 30, 2007
CISBIO RENIN RIA TEST
CIB
Radioimmunoassay, Angiotensin I And Renin
248d
Cleared
Mar 28, 2007
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
MSJ
Apolipoproteins
315d
Cleared
Mar 23, 2007
OLYMPUS TRIGLYCERIDE TEST SYSTEM
CDT
Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
91d
Cleared
Mar 23, 2007
THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401
JFY
Enzymatic Method, Creatinine
305d
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