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 25, 2006
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
KHS
Enzymatic, Carbon-dioxide
22d
Cleared
May 25, 2006
CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2
JJY
Multi-analyte Controls, All Kinds (assayed)
28d
Cleared
May 25, 2006
ARCHITECT BNP ASSAY, MODEL 8K28
NBC
Test, Natriuretic Peptide
48d
Cleared
May 25, 2006
CLEARBLUE EASY DIGITAL PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
127d
Cleared
May 25, 2006
PURE-AID PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
164d
Cleared
May 19, 2006
ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
28d
Cleared
May 19, 2006
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
DKZ
Enzyme Immunoassay, Amphetamine
169d
Cleared
May 17, 2006
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
CFR
Hexokinase, Glucose
30d
Cleared
May 15, 2006
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
DQD
Stethoscope, Electronic
95d
Cleared
May 10, 2006
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
CKA
Nadh Oxidation/nad Reduction, Alt/sgpt
27d
Cleared
May 05, 2006
GLUCOSE
CFR
Hexokinase, Glucose
80d
Cleared
May 04, 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
NQD
Cardiac C-reactive Protein, Antigen, Antiserum, And Control
80d
Cleared
May 04, 2006
CARBON DIOXIDE
KHS
Enzymatic, Carbon-dioxide
87d
Cleared
May 03, 2006
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
CKG
Radioimmunoassay, Acth
57d
Cleared
May 03, 2006
TOTAL BILIRUBIN
CIG
Diazo Colorimetry, Bilirubin
58d
Cleared
Apr 28, 2006
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
CGX
Alkaline Picrate, Colorimetry, Creatinine
23d
Cleared
Apr 28, 2006
IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6
CDD
Radioassay, Vitamin B12
23d
Cleared
Apr 28, 2006
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
43d
Cleared
Apr 28, 2006
NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
CGA
Glucose Oxidase, Glucose
77d
Cleared
Apr 28, 2006
CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
DCK
C-reactive Protein, Antigen, Antiserum, And Control
99d
Cleared
Apr 26, 2006
DRI-STAT ACID PHOSPHATASE REAGENT
CKB
Acid Phosphatase, Naphthyl Phosphate
120d
Cleared
Apr 24, 2006
CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250
JIT
Calibrator, Secondary
95d
Cleared
Apr 24, 2006
RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC
DJG
Enzyme Immunoassay, Opiates
222d
Cleared
Apr 21, 2006
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
CGN
Acid, Folic, Radioimmunoassay
30d
Cleared
Apr 21, 2006
PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
JIN
Nitroprusside, Ketones (urinary, Non-quant.)
30d
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