KZR · Chromatography (Liquid, Gel), Clinical Use
Clinical Chemistry · 21 CFR 862.2260 · Class 1
Overview
| Product Code | KZR |
|---|---|
| Device Name | Chromatography (Liquid, Gel), Clinical Use |
| 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973074 | 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR | Waters Corporation | Oct 6, 1997 | SESE |
| K931227 | USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 | U.S. Drug Testing, Inc. | May 6, 1993 | SESE |
| K905538 | COLUMNS LIQUID CHROMATOGRAPHY DPM | Millpore Corp. | Jan 25, 1991 | SESE |
| K861392 | SYVA SOLID PHASE COLUMNS SYSTEM II | Syva Co. | Jun 13, 1986 | SESE |
| K860197 | SERIES 410 LC PUMP | The Perkin-Elmer Corp. | Mar 17, 1986 | SESE |
| K851945 | VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM | Varian Assoc., Inc. | May 24, 1985 | SESE |
| K843568 | LIQUID CHROMATOGRAPH 400 | The Perkin-Elmer Corp. | Nov 20, 1984 | SESE |
| K841890 | VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY | Varian Assoc., Inc. | Jun 14, 1984 | SESE |
| K840977 | LIQUID CHROMATOGRAPHIC DETECTOR LC-95 | The Perkin-Elmer Corp. | Apr 19, 1984 | SESE |
| K832201 | CHROM-PREP | Hamilton Co. | Aug 16, 1983 | SESE |
| K802725 | VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS | Varian Assoc., Inc. | Dec 11, 1980 | SESE |
| K780945 | LIQUID CHROMATOGRAPH MODEL 860 | E.I. Dupont DE Nemours & Co., Inc. | Jul 27, 1978 | SESE |
| K780944 | LIQUID CHROMATOGRAPH MODEL 850 | E.I. Dupont DE Nemours & Co., Inc. | Jul 27, 1978 | SESE |
| K770255 | LC-65T DETECTOR AND OVEN | The Perkin-Elmer Corp. | Feb 25, 1977 | SESE |
| K770254 | CHROMATOGRAPH, SERIES 3, LIQUID | The Perkin-Elmer Corp. | Feb 24, 1977 | SESE |
Top Applicants
- The Perkin-Elmer Corp. — 5 clearances
- Varian Assoc., Inc. — 3 clearances
- E.I. Dupont DE Nemours & Co., Inc. — 2 clearances
- Hamilton Co. — 1 clearance
- Millpore Corp. — 1 clearance
