DPM · Columns, Liquid Chromatography
Clinical Chemistry · 21 CFR 862.2260 · Class 1
Overview
| Product Code | DPM |
|---|---|
| Device Name | Columns, Liquid Chromatography |
| Regulation | 21 CFR 862.2260 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
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.
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952501 | TOX PERFECT B TUBES AND REAGENTS | Chimera Research & Chemical, Inc. | Aug 24, 1995 | SESE |
| K895105 | HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE | Waters Chemical Products | Oct 6, 1989 | SESE |
| K894141 | LIQUID CHROMATOGRAPHY COLUMNS | Supelco, Inc. | Aug 21, 1989 | SESE |
| K891673 | ADVANCED PURIFICATION GLASS COLUMN | Waters Chemical Products | Apr 26, 1989 | SESE |
| K884403 | LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE | Supelco, Inc. | Dec 22, 1988 | SESE |
| K881868 | LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD | Supelco, Inc. | Aug 29, 1988 | SESE |
| K880724 | LIQUID CHROMATO. COLUMNS | Supelco, Inc. | May 27, 1988 | SESE |
| K864267 | SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY) | Millipore Corp. | Jan 9, 1987 | SESE |
| K862541 | LIQUID CHROMATOGRAPHY COLUMNS | Supelco, Inc. | Jul 29, 1986 | SESE |
| K861633 | LIQUID CHROMATOGRAPHY COLUMNS | Supelco, Inc. | May 23, 1986 | SESE |
| K842909 | LIQUID CHROMATOGRAPHY COLUMNS;ION EXCH | Supelco, Inc. | Oct 5, 1984 | SESE |
| K832200 | PRP-1 REVERSED PHASE COLUMNS FOR HPLC | Hamilton Co. | Aug 16, 1983 | SESE |
| K813575 | LIQUID CHROMATOGRAPHY (HPLC) COLUMNS | Supelco, Inc. | Jan 18, 1982 | SESE |
| K811304 | LIQUID CHROMATOGRAPHY COLUMNS | Supelco, Inc. | May 27, 1981 | SESE |
| K802703 | LIQUID CHROMATOGRAPHY COLUMNS | Supelco, Inc. | Nov 12, 1980 | SESE |
| K761168 | MAX L SYSTEM | Brinkman Instruments, Inc. | Dec 10, 1976 | SESE |
Top Applicants
- Supelco, Inc. — 10 clearances
- Waters Chemical Products — 2 clearances
- Millipore Corp. — 1 clearance
- Hamilton Co. — 1 clearance
- Chimera Research & Chemical, Inc. — 1 clearance
