Rubella Elisa Reagents Rubella Igg Anti
FDA 510(k) K802102 · Calbiochem-Behring Corp.
510(k) numberK802102
Submission
- Device name
- Rubella Elisa Reagents Rubella Igg Anti
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- September 3, 1980
- Decision date
- December 18, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GOL – Antigen, Ha (Including Ha Control), Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
Other 510(k)s with product code GOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K841174 | Rubella Antibody FluoroimmunoassayGOL · Traditional | Intl. Diagnostic Technology | 06/07/1984SE |
| K834032 | Rubaquick Diagnostic KitGOL · Traditional | Abbott Laboratories | 04/17/1984SE |
| K810309 | Rubella Antibodies Test ReagentsGOL · Traditional | Calbiochem-Behring Corp. | 03/11/1981SE |
| K802508 | Rubelisa Igm Test KitGOL · Traditional | M.A. Bioproducts | 12/18/1980SE |
| K802339 | Eia Rubella-GGOL · Traditional | Beckman Instruments, Inc. | 12/18/1980SE |
| K801667 | Gamma COAT(125 I) Rubella AntibodyGOL · Traditional | Clinical Assays, Inc. | 10/23/1980SE |
| K801098 | Enzyme-Immunoassay (Rubella Antibodies)GOL · Traditional | Flow Laboratories, Inc. | 09/16/1980SE |
| K801507 | Antigen Control CellsGOL · Traditional | Ortho Diagnostics, Inc. | 08/20/1980SE |
| K800789 | Rubella Bio-Bead Titration KitGOL · Traditional | Litton Bionetics | 06/30/1980SE |
| K800797 | Macro-Vue Rubella Card TestGOL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/20/1980SE |
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| 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 Rubella Elisa Reagents Rubella Igg Anti cleared by the FDA?
Rubella Elisa Reagents Rubella Igg Anti (K802102) received a 510(k) decision of Substantially Equivalent on December 18, 1980, 106 days after the submission was received.
What is the product code of K802102?
The FDA product code is GOL – Antigen, Ha (Including Ha Control), Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.