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.
13234
Total
13203
Cleared
199d
Avg (2y)
1976
Since
8200 Chemistry devices
Cleared
Dec 24, 2013
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
134d
Cleared
Dec 20, 2013
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
318d
Cleared
Dec 19, 2013
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
167d
Cleared
Dec 18, 2013
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
JGS
Electrode, Ion Specific, Sodium
138d
Cleared
Dec 04, 2013
ELECSYS CALCITONIN
JKR
Radioimmunoassay, Calcitonin
86d
Cleared
Nov 26, 2013
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
JIX
Calibrator, Multi-analyte Mixture
25d
Cleared
Nov 22, 2013
ELECSYS CK-MB CALCHECK 5
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
28d
Cleared
Nov 22, 2013
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
CDT
Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
56d
Cleared
Nov 21, 2013
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
CGS
Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
330d
Cleared
Nov 08, 2013
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
CEW
Radioimmunoassay, Parathyroid Hormone
88d
Cleared
Oct 25, 2013
IMMULITE 2000
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
25d
Cleared
Oct 25, 2013
LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY
JJY
Multi-analyte Controls, All Kinds (assayed)
100d
Cleared
Oct 23, 2013
RANDOX CSF CONTROLS LEVELS 2 AND 3
JJY
Multi-analyte Controls, All Kinds (assayed)
104d
Cleared
Oct 22, 2013
IMMULITE 2000
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
22d
Cleared
Oct 18, 2013
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
JHY
Colorimetric Method, Cpk Or Isoenzymes
64d
Cleared
Oct 17, 2013
FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
189d
Cleared
Oct 16, 2013
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
CJW
Bromcresol Purple Dye-binding, Albumin
50d
Cleared
Oct 10, 2013
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
125d
Cleared
Oct 01, 2013
ACCESS TOTAL BHCG (5TH IS)
DHA
System, Test, Human Chorionic Gonadotropin
271d
Cleared
Sep 25, 2013
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
MMI
Immunoassay Method, Troponin Subunit
464d
Cleared
Sep 13, 2013
ADVIA CENTAUR FT4, ADVIA CENTAUR T4
CEC
Radioimmunoassay, Free Thyroxine
56d
Cleared
Sep 06, 2013
LIAISON XL HCG
DHA
System, Test, Human Chorionic Gonadotropin
144d
Cleared
Sep 05, 2013
LIAISON 25 TOTAL-D
MRG
System, Test, Vitamin D
27d
Cleared
Aug 20, 2013
THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
OUF
Everolimus Immunoassay
344d
Cleared
Aug 02, 2013
SOFIA(R) HCG FIA
JHI
Visual, Pregnancy Hcg, Prescription Use
100d
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