HC40/HC75 Prepacked Colums
FDA 510(k) K832198 · Hamilton Co.
510(k) numberK832198
Submission
- Device name
- HC40/HC75 Prepacked Colums
- Applicant
- Hamilton Co.
Mchenry, IL, US - Received
- July 7, 1983
- Decision date
- August 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DJY – Ion-Exchange Chromatography
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2230
- Specialty
- Clinical Chemistry
Other 510(k)s with product code DJY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K890113 | The Cdi(R) System 400DJY · Traditional | Cardiovascular Devices, Inc. | 05/23/1989SE |
| K883615 | Liquid Chromatography Columns 5-7070/71/72/73DJY · Traditional | Supelco, Inc. | 12/16/1988SE |
| K881361 | Solid Phase Extraction TubesDJY · Traditional | Supelco, Inc. | 08/08/1988SE |
| K850963 | Dupont Prep Type Si Extraciton CartridgeDJY · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/25/1985SE |
| K840985 | Trisacryl GF 05 & Trisacryl GF 2000DJY · Traditional | Lkb Instruments, Inc. | 04/19/1984SE |
| K831289 | Prefilled Iec ColumnsDJY · Traditional | Berwick Medical Products, Inc. | 06/16/1983SE |
| K830693 | Dupont Prep Type AS Extraction CartrideDJY · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/05/1983SE |
| K830692 | Dupont Prep Od Extraction CartrideDJY · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/05/1983SE |
| K823697 | Prep Type a Extraction CartridgeDJY · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 01/05/1983SE |
| K800061 | Bond Elut ColumnsDJY · Traditional | Analytichem International, Inc. | 03/12/1980SE |
More from Analytichem International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961896 | Microlab 4000, Microlab 4200JQW · Traditional | 08/16/1996SE |
| K943493 | Discrete Photometric Chemistry AnalyzerJJE · Traditional | 01/30/1995SE |
| K892369 | Multi-Probe Head PlusJTC · Traditional | 06/02/1989SE |
| K873893 | LumiconJJQ · Traditional | 01/05/1988SE |
| K871945 | Microlab atJTC · Traditional | 05/29/1987SE |
| K832205 | Precision Liquid DispenserJQW · Traditional | 08/24/1983SE |
| K832204 | Microlab PJQW · Traditional | 08/24/1983SE |
| K832202 | PB 600 Repeating DispenserJQW · Traditional | 08/24/1983SE |
| K832201 | Chrom-PrepKZR · Traditional | 08/16/1983SE |
| K832200 | PRP-1 Reversed Phase Columns for HPLCDPM · Traditional | 08/16/1983SE |
Questions and answers
When was HC40/HC75 Prepacked Colums cleared by the FDA?
HC40/HC75 Prepacked Colums (K832198) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 36 days after the submission was received.
What is the product code of K832198?
The FDA product code is DJY – Ion-Exchange Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2230.