Immunoglobulin E Test Kit
FDA 510(k) K800995 · Calbiochem-Behring Corp.
510(k) numberK800995
Submission
- Device name
- Immunoglobulin E Test Kit
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- April 25, 1980
- Decision date
- May 14, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
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|---|---|---|
| K831811 | Revolution Radial Immunodiffusion PlateJZQ · Traditional | 07/28/1983SE |
| K831036 | Ena Test Kit SM & RNP Auto AntibodyLLL · Traditional | 04/27/1983SE |
| K830214 | Aft System IIIDHN · Traditional | 03/09/1983SE |
| K820812 | Creatine Kinase-Mb KitJHY · Traditional | 04/12/1982SE |
| K813493 | Enzygnost TM Rubella IgmLFX · Traditional | 03/04/1982SE |
| K820088 | Aft System Proficiency Testing ProgramDBL · Traditional | 01/26/1982SE |
| K812458 | PadacJTO · Traditional | 09/23/1981SE |
| K810718 | C-Peptice ReagentsJKD · Traditional | 03/31/1981SE |
| K810669 | Pantrak E.K.CIW · Traditional | 03/31/1981SE |
| K810404 | Rheumatoid Factors Reference SerumDHR · Traditional | 03/11/1981SE |
Questions and answers
When was Immunoglobulin E Test Kit cleared by the FDA?
Immunoglobulin E Test Kit (K800995) received a 510(k) decision of Substantially Equivalent on May 14, 1980, 19 days after the submission was received.
What is the product code of K800995?
The FDA product code is DGO – Ige, Peroxidase, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.