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
3210 Chemistry devices
Cleared
Jun 25, 1986
DOUBLE ANTIBODY CALCITONIN RIA KIT
JKR
Radioimmunoassay, Calcitonin
79d
Cleared
Jun 17, 1986
VISION ALBUMIN
CJW
Bromcresol Purple Dye-binding, Albumin
13d
Cleared
Jun 17, 1986
VISION TOTAL PROTEIN
CEK
Biuret (colorimetric), Total Protein
39d
Cleared
Jun 16, 1986
SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
28d
Cleared
Jun 13, 1986
SYVA SOLID PHASE COLUMNS SYSTEM II
KZR
Chromatography (liquid, Gel), Clinical Use
60d
Cleared
Jun 11, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA)
CGX
Alkaline Picrate, Colorimetry, Creatinine
30d
Cleared
Jun 11, 1986
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
CHH
Enzymatic Esterase--oxidase, Cholesterol
37d
Cleared
May 29, 1986
CK/LD BUFFER (CAT. NO. 5808)
CFE
Electrophoretic, Lactate Dehydrogenase Isoenzymes
23d
Cleared
May 29, 1986
EMIT DIGOXIN MOBILE PHASE SOLUTION
KXT
Enzyme Immunoassay, Digoxin
45d
Cleared
May 29, 1986
EMIT COLUMN DIGOXIN ASSAY
KXT
Enzyme Immunoassay, Digoxin
45d
Cleared
May 29, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)
KLS
Enzyme Immunoassay, Theophylline
48d
Cleared
May 23, 1986
CONTROL SERA LEVEL VALUES (MG/DL)
JJY
Multi-analyte Controls, All Kinds (assayed)
25d
Cleared
May 23, 1986
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
JJT
Enzyme Controls (assayed And Unassayed)
30d
Cleared
May 23, 1986
DIRECT READOUT MODULE ACCESSORY
JQP
Calculator/data Processing Module, For Clinical Use
38d
Cleared
May 23, 1986
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
CIJ
Saccharogenic, Amylase
72d
Cleared
May 07, 1986
EMIT COLUMN DIGOXIN CALIBRATORS
DLJ
Calibrators, Drug Specific
23d
Cleared
May 05, 1986
VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM
CIT
Nadh Oxidation/nad Reduction, Ast/sgot
88d
Cleared
May 01, 1986
VMA BY HPLC TEST (VANILMANDELIC ACID)
CDF
Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin
44d
Cleared
Apr 24, 1986
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
23d
Cleared
Apr 24, 1986
EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK
CGS
Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
35d
Cleared
Apr 24, 1986
EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
36d
Cleared
Apr 24, 1986
COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT
JLX
Radioimmunoassay, 17-hydroxyprogesterone
85d
Cleared
Apr 21, 1986
VISION SGPT (ALT)
CKA
Nadh Oxidation/nad Reduction, Alt/sgpt
34d
Cleared
Apr 17, 1986
HITACHI 736
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
49d
Cleared
Apr 17, 1986
ES600 IMMUNOASSAY SYSTEM
JJE
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
56d
Looking for a specific chemistry device? Search by device name, K-number or manufacturer.
Search all Chemistry 510(k) devices