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.
13224
Total
13193
Cleared
208d
Avg (2y)
1976
Since
3201 Chemistry devices
Cleared
Jan 25, 2001
ELECSYS HCG STAT CLASET II
JIS
Calibrator, Primary
35d
Cleared
Jan 25, 2001
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD
DHA
System, Test, Human Chorionic Gonadotropin
56d
Cleared
Jan 17, 2001
ELECSYS DHEA-S
JKC
Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
99d
Cleared
Dec 22, 2000
SYNCHRON SYSTEMS AMMONIA REAGENT
JIF
Enzymatic Method, Ammonia
71d
Cleared
Dec 20, 2000
ELECSYS DHEA-S CALCHECK
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
14d
Cleared
Dec 18, 2000
ROCHE DIAGNOSTICS CK-MB
JHW
U.v. Method, Cpk Isoenzymes
69d
Cleared
Dec 14, 2000
ELECSYS HCG AND BETA TEST SYSTEM
DHA
System, Test, Human Chorionic Gonadotropin
64d
Cleared
Nov 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623
JJS
Controls For Blood-gases, (assayed And Unassayed)
44d
Cleared
Nov 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506
JJS
Controls For Blood-gases, (assayed And Unassayed)
44d
Cleared
Nov 27, 2000
N/T PROTEIN CONTROL SL
JJY
Multi-analyte Controls, All Kinds (assayed)
75d
Cleared
Nov 20, 2000
ACCESS ULTRASENSITIVE HGH CALIBRATORS
JIT
Calibrator, Secondary
48d
Cleared
Nov 16, 2000
CREATININE PLUS
JFY
Enzymatic Method, Creatinine
29d
Cleared
Nov 13, 2000
SOF-TACT DIABETES MANAGEMENT SYSTEM
LFR
Glucose Dehydrogenase, Glucose
137d
Cleared
Oct 11, 2000
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
LDP
Colorimetry, Acetaminophen
55d
Cleared
Oct 11, 2000
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL
LEG
Enzyme Immunoassay, Valproic Acid
55d
Cleared
Oct 05, 2000
N PROTEIN STANDARD SL
JIX
Calibrator, Multi-analyte Mixture
27d
Cleared
Oct 05, 2000
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
CFF
Immunoelectrophoretic, Immunoglobulins, (g, A, M)
27d
Cleared
Oct 05, 2000
ELECSYS DHEA-S CALSET
JIS
Calibrator, Primary
30d
Cleared
Sep 25, 2000
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574
JJS
Controls For Blood-gases, (assayed And Unassayed)
12d
Cleared
Sep 25, 2000
LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578
JJS
Controls For Blood-gases, (assayed And Unassayed)
12d
Cleared
Sep 05, 2000
CAMIT DIABETES MANAGEMENT SOFTWARE
CGA
Glucose Oxidase, Glucose
75d
Cleared
Aug 31, 2000
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642
JJY
Multi-analyte Controls, All Kinds (assayed)
21d
Cleared
Aug 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)
JJS
Controls For Blood-gases, (assayed And Unassayed)
14d
Cleared
Aug 30, 2000
LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513
JJS
Controls For Blood-gases, (assayed And Unassayed)
14d
Cleared
Aug 22, 2000
ELECSYS HCG TEST SYSTEM
DHA
System, Test, Human Chorionic Gonadotropin
36d
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