Anesthesiology
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- DIIColumns, Glc1Product Code
- DJAColumn Supports, Glc1Product Code
- DJOIndicator, Cellulose Fluorescent, Tlc1Product Code
- DJSU.V. Light, Tlc1Product Code
- DJYIon-Exchange Chromatography1Product Code
- DKGPlate, Cellulose, Tlc1Product Code
- DKKTanks, Developing, Tlc1Product Code
- DKOAdsorbents, Ion-Exchange1Product Code
- DKSPlate, Silica Gel, Tlc1Product Code
- DKYIndicator, Alumina Fluorescent, Tlc1Product Code
- DLCAtomizer, Tlc1Product Code
- DLGCoating, Liquid, Glc1Product Code
- DLOIndicator, Silica Gel Fluorescent, Tlc1Product Code
- DLYPlate, Alumina, Tlc1Product Code
- DMGPapers, Ion1Product Code
- DMSGases, Glc1Product Code
- DMZLiquid Chromatography, Adsorbent1Product Code
- DNHResins, Ion-Exchange, Liquid Chromatography1Product Code
- DOPMass Spectrometer, Clinical Use1Product Code
- DPAApparatus, General Use, Thin Layer Chromatography1Product Code
- DPMColumns, Liquid Chromatography1Product Code
- JSQChromatography For Bacterial Identification1Product Code
- JXQMonitor, U.V., Glc1Product Code
- JXRAtomic Absorption Spectrophotometer, General Use1Product Code
- KEAResins, Ion-Exchange1Product Code
- KIEApparatus, High Pressure Liquid Chromatography1Product Code
- KZQChromatography(Gas), Clinical Use1Product Code
- KZRChromatography (Liquid, Gel), Clinical Use1Product Code
- KZSChromatography (Thin Layer), Clinical Use1Product Code
- LDMInstrumentation, High Pressure Liquid Chromatography1Product Code
- LEQDetectors, Electrochemical, Liquid Chromatography1Product Code
- PFFHigh Throughput Dna Sequence Analyzer2Product Code
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Medical GeneticsReview Panel
- UnknownReview Panel
Ion-Exchange Chromatography
- Page Type
- Product Code
- Regulation Medical Specialty
- Chemistry
- Review Panel
- Toxicology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 862.2230
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 862.2230 Chromatographic separation material for clinical use
§ 862.2230 Chromatographic separation material for clinical use.
(a) Identification. A chromatographic separation material for clinical use is a device accessory (e.g., ion exchange absorbents, ion exchagne resins, and ion papers) intended for use in ion exchange chromatography, a procedure in which a compound is separated from a solution.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
[52 FR 16122, May 1, 1987, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38788, July 25, 2001]