Trisacryl GF 05 & Trisacryl GF 2000
FDA 510(k) K840985 · Lkb Instruments, Inc.
510(k) numberK840985
Submission
- Device name
- Trisacryl GF 05 & Trisacryl GF 2000
- Applicant
- Lkb Instruments, Inc.
Mchenry, IL, US - Received
- March 7, 1984
- Decision date
- April 19, 1984
- 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 |
| K832198 | HC40/HC75 Prepacked ColumsDJY · Traditional | Hamilton Co. | 08/12/1983SE |
| 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 |
|---|---|---|
| K874094 | 1205 Betaplate Liquid Scintillation CounterJJJ · Traditional | 11/04/1987SE |
| K872955 | Delfia(Tm) Ferritin KitJMG · Traditional | 08/21/1987SE |
| K871303 | Delfia(Tm) Thyroxine (T4) KitCDX · Traditional | 06/17/1987SE |
| K871599 | Delfia(Tm) Hige KitDHB · Traditional | 06/12/1987SE |
| K871644 | Delfia (TM) HTSH KitJLW · Traditional | 05/12/1987SE |
| K864452 | Delfia(Tm) Triiodothyronine (T3) KitCDP · Traditional | 02/02/1987SE |
| K864733 | LKB 2260 MacrotomeIDO · Traditional | 01/05/1987SE |
| K862848 | LKB Ultrobact (TM) Pneumococcus Kit; 2321-110GWC · Traditional | 12/18/1986SE |
| K863422 | Delfia(Tm) Cortisol KitJFT · Traditional | 09/26/1986SE |
| K862044 | Delfia (TM) HCG KitJHJ · Traditional | 07/11/1986SE |
Questions and answers
When was Trisacryl GF 05 & Trisacryl GF 2000 cleared by the FDA?
Trisacryl GF 05 & Trisacryl GF 2000 (K840985) received a 510(k) decision of Substantially Equivalent on April 19, 1984, 43 days after the submission was received.
What is the product code of K840985?
The FDA product code is DJY – Ion-Exchange Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2230.