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
Mar 08, 2013
FASTPACK CONTROL KIT
JJY
Multi-analyte Controls, All Kinds (assayed)
94d
Cleared
Mar 08, 2013
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
CGA
Glucose Oxidase, Glucose
455d
Cleared
Mar 07, 2013
DIMENSION VISTA
JIF
Enzymatic Method, Ammonia
97d
Cleared
Mar 07, 2013
GENESIS HEALTH RECORD SYSTEM, (GHRS)
NBW
System, Test, Blood Glucose, Over The Counter
153d
Cleared
Mar 01, 2013
LIQUID ASSAYED MULTIQUAL PREMIUM
JJY
Multi-analyte Controls, All Kinds (assayed)
37d
Cleared
Mar 01, 2013
EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
CIG
Diazo Colorimetry, Bilirubin
81d
Cleared
Feb 28, 2013
COBAS INTEGRA BILIRUBIN DIRECT GEN.2
CIG
Diazo Colorimetry, Bilirubin
64d
Cleared
Feb 15, 2013
PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
CHH
Enzymatic Esterase--oxidase, Cholesterol
18d
Cleared
Feb 15, 2013
DIMENSION CHEMISTRY III CALIBRATORY
JIX
Calibrator, Multi-analyte Mixture
112d
Cleared
Feb 15, 2013
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
JIF
Enzymatic Method, Ammonia
112d
Cleared
Feb 15, 2013
ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
JIT
Calibrator, Secondary
207d
Cleared
Feb 15, 2013
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
MRG
System, Test, Vitamin D
259d
Cleared
Feb 14, 2013
GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
62d
Cleared
Feb 14, 2013
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
LFR
Glucose Dehydrogenase, Glucose
276d
Cleared
Feb 12, 2013
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
434d
Cleared
Feb 11, 2013
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
872d
Cleared
Feb 08, 2013
ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI
MRG
System, Test, Vitamin D
127d
Cleared
Feb 07, 2013
TOXCUP DRUG SCREEN CUP
LDJ
Enzyme Immunoassay, Cannabinoids
162d
Cleared
Feb 07, 2013
ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
336d
Cleared
Feb 07, 2013
ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
NBW
System, Test, Blood Glucose, Over The Counter
349d
Cleared
Feb 05, 2013
EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
130d
Cleared
Feb 01, 2013
ARCHITECT TOTAL BILIRUBIN
CIG
Diazo Colorimetry, Bilirubin
210d
Cleared
Feb 01, 2013
AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM
KQO
Automated Urinalysis System
261d
Cleared
Jan 31, 2013
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK
JJY
Multi-analyte Controls, All Kinds (assayed)
52d
Cleared
Jan 25, 2013
GLUCOSE METER-CHECK SOLUTION FOR BAYER
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
30d
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