Ion-Exchange Chromatography
Ion-Exchange Chromatography is a laboratory technique and associated equipment used to separate, purify, and quantify compounds in biological or chemical specimens based on their ionic charge interactions, with applications spanning clinical chemistry, biochemistry, and toxicology testing. This device is classified as FDA Class 1, indicating low risk, and is subject only to general controls without premarket notification. It is regulated under 21 CFR 862.2230 within the Clinical Chemistry specialty.
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Basic Information
- Product Code
- DJY
- Device Class
- FDA class 1
- Regulation Number
- 862.2230
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K890113 | THE CDI(R) SYSTEM 400 | May 23, 1989 | Substantially Equivalent | Cardiovascular Devices, Inc. |
| K883615 | LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 | Dec 16, 1988 | Substantially Equivalent | Supelco, Inc. |
| K881361 | SOLID PHASE EXTRACTION TUBES | Aug 08, 1988 | Substantially Equivalent | Supelco, Inc. |
| K850963 | DUPONT PREP TYPE SI EXTRACITON CARTRIDGE | Mar 25, 1985 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K840985 | TRISACRYL GF 05 & TRISACRYL GF 2000 | Apr 19, 1984 | Substantially Equivalent | Lkb Instruments, Inc. |
| K832198 | HC40/HC75 PREPACKED COLUMS | Aug 12, 1983 | Substantially Equivalent | Hamilton Co. |
| K831289 | PREFILLED IEC COLUMNS | Jun 16, 1983 | Substantially Equivalent | Berwick Medical Products, Inc. |
| K830693 | DUPONT PREP TYPE AS EXTRACTION CARTRIDE | Apr 05, 1983 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K830692 | DUPONT PREP OD EXTRACTION CARTRIDE | Apr 05, 1983 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K823697 | PREP TYPE A EXTRACTION CARTRIDGE | Jan 05, 1983 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K800061 | BOND ELUT COLUMNS | Mar 12, 1980 | Substantially Equivalent | Analytichem International, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.