Reactifs, Ibf Ultrogels Aca & Ultrogels a
FDA 510(k) K844164 · Lkb Instruments, Inc.
510(k) numberK844164
Submission
- Device name
- Reactifs, Ibf Ultrogels Aca & Ultrogels a
- Applicant
- Lkb Instruments, Inc.
Gaithersburg, MD, US - Received
- October 25, 1984
- Decision date
- December 10, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DII – Columns, Glc
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2250
- Specialty
- Clinical Chemistry
Other 510(k)s with product code DII
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874824 | Capillary Columns for Gas ChromatographyDII · Traditional | Supelco, Inc. | 01/21/1988SE |
| K862542 | Capillary Columns for Gas ChromatographyDII · Traditional | Supelco, Inc. | 08/04/1986SE |
| K841712 | Capillary Gas Chromatographic ColumnsDII · Traditional | Supelco, Inc. | 05/21/1984SE |
| K791893 | 19091-XXXXX Ser. of Glass Capillary Col.DII · Traditional | Hewlett-Packard Co. | 10/30/1979SE |
More from Hewlett-Packard Co.
| 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 Reactifs, Ibf Ultrogels Aca & Ultrogels a cleared by the FDA?
Reactifs, Ibf Ultrogels Aca & Ultrogels a (K844164) received a 510(k) decision of Substantially Equivalent on December 10, 1984, 46 days after the submission was received.
What is the product code of K844164?
The FDA product code is DII – Columns, Glc, a Class I (low risk) device regulated under 21 CFR 862.2250.