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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
Instrumentation, High Pressure Liquid Chromatography
- Page Type
- Product Code
- Regulation Medical Specialty
- Chemistry
- Review Panel
- Toxicology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 862.2260
- 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 § 862.2260 High pressure liquid chromatography system for clinical use
§ 862.2260 High pressure liquid chromatography system for clinical use.
(a) Identification. A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.
(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 § 862.9.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]