Immulite(R) Allergy Food Panel FP5E
FDA 510(k) K943194 · Diagnostic Products Corp.
510(k) numberK943194
Submission
- Device name
- Immulite(R) Allergy Food Panel FP5E
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- July 5, 1994
- Decision date
- February 23, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DGO – Ige, Peroxidase, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K920087 | Ige Eia Test KitDGO · Traditional | The Binding Site, Ltd. | 09/14/1992SE |
| K911511 | Alastat Allergen Specified Ige System, ModifiedDGO · Traditional | Diagnostic Products Corp. | 04/17/1991SE |
| K894039 | Quidel Total Ige Test Quantitative VersionDGO · Traditional | Quidel Corp. | 07/14/1989SE |
| K893125 | Beckman Epsilon(Tm) Ige Reagent KitDGO · Traditional | Beckman Instruments, Inc. | 06/16/1989SE |
| K872801 | Alleia Total Ige Eia W/Mono Anti. EKIE1, 2, 5DGO · Traditional | Diagnostic Products Corp. | 09/10/1987SE |
| K860851 | Allegro Ige Enzyme Immunoassay SystemDGO · Traditional | Nichols Institute Diagnostics | 03/28/1986SE |
| K853607 | Allerg-E Ige Enzyme Immunoassay KitDGO · Traditional | Dexall Biomedical Labs, Inc. | 11/07/1985SE |
| K831984 | Polystyrene Micro-Liter Plate-BirchtreeDGO · Traditional | Diagnostic Reagent Tech. | 11/21/1983SE |
| K831987 | Epsilon Ige Test KitDGO · Traditional | Beckman Instruments, Inc. | 10/14/1983SE |
| K831774 | Logipe a Data Reducsystem Ip Specific-DGO · Traditional | Diagnostic Reagent Tech. | 07/18/1983SE |
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Questions and answers
When was Immulite(R) Allergy Food Panel FP5E cleared by the FDA?
Immulite(R) Allergy Food Panel FP5E (K943194) received a 510(k) decision of Substantially Equivalent on February 23, 1995, 233 days after the submission was received.
What is the product code of K943194?
The FDA product code is DGO – Ige, Peroxidase, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.