Rubella Antibody Fluoroimmunoassay
FDA 510(k) K841174 · Intl. Diagnostic Technology
510(k) numberK841174
Submission
- Device name
- Rubella Antibody Fluoroimmunoassay
- Applicant
- Intl. Diagnostic Technology
Walker, MI, US - Received
- March 19, 1984
- Decision date
- June 7, 1984
- 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 |
|---|---|---|---|
| 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 |
| K802102 | Rubella Elisa Reagents Rubella Igg AntiGOL · Traditional | Calbiochem-Behring Corp. | 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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|---|---|---|
| K850591 | Fiax Toxo-M Antibodies Test KitGLZ · Traditional | 04/30/1985SE |
| K843570 | Fiax Haptoglobin Test KitDAB · Traditional | 10/05/1984SE |
| K843621 | Fiax 420 DilutorJQW · Traditional | 09/28/1984SE |
| K843356 | Fiax 100 FluorometerJZT · Traditional | 09/17/1984SE |
| K842749 | Fiax Total Ige Test KitDGP · Traditional | 08/28/1984SE |
| K842071 | Fiax Transferrin Test KitDDI · Traditional | 07/11/1984SE |
| K840867 | ALPHA-1-ANTITRYPSIN, Fitc, AntigenDEI · Traditional | 05/11/1984SE |
| K834140 | Antinuclear Antibody Immunological SysKTL · Traditional | 01/20/1984SE |
| K833984 | Antinuclear Antibody ImmunologicalKTL · Traditional | 01/04/1984SE |
| K832821 | Fiax Igg TestDFI · Traditional | 10/14/1983SE |
Questions and answers
When was Rubella Antibody Fluoroimmunoassay cleared by the FDA?
Rubella Antibody Fluoroimmunoassay (K841174) received a 510(k) decision of Substantially Equivalent on June 7, 1984, 80 days after the submission was received.
What is the product code of K841174?
The FDA product code is GOL – Antigen, Ha (Including Ha Control), Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.