Anesthesiology
Review Panel
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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
Apparatus, General Use, Thin Layer Chromatography
- Page Type
- Product Code
- Regulation Medical Specialty
- Chemistry
- Review Panel
- Toxicology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 862.2270
- GMP Exempt?
- Yes
- 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 § 862.2270 Thin-layer chromatography system for clinical use
§ 862.2270 Thin-layer chromatography system for clinical use.
(a) Identification. A thin-layer chromatography (TLC) system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. The mixture of compounds is absorbed onto a stationary phase or thin layer of inert material (e.g., cellulose, alumina, etc.) and eluted off by a moving solvent (moving phase) until equilibrium occurs between the two phases.
(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. Particular components of TLC systems, i.e., the thin-layer chromatography apparatus, TLC atomizer, TLC developing tanks, and TLC ultraviolet light, are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]