Rubella Virus Antigens & Controls
FDA 510(k) K802937 · Orion Diagnostica, Inc.
510(k) numberK802937
Submission
- Device name
- Rubella Virus Antigens & Controls
- Applicant
- Orion Diagnostica, Inc.
Mchenry, IL, US - Received
- November 19, 1980
- Decision date
- December 31, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GON – Antigen, Cf (Including Cf Control), Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
Other 510(k)s with product code GON
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K894262 | Rubella Antigen and Control AntigenGON · Traditional | Microbix Biosystems, Inc. | 10/16/1989SE |
| K880157 | Microtrak HSV 1/HSV 2 Culture Identi./Typing TestGON · Traditional | Syva Co. | 02/04/1988SE |
| K802939 | Herpes Simplex Type IGON · Traditional | Orion Diagnostica, Inc. | 12/31/1980SE |
| K780996 | Rubelisa Test KitGON · Traditional | Microbiological Assoc. | 11/22/1978SE |
More from Microbiological Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and…DCK · Traditional | 03/10/2016SE |
| K043125 | Orion Diagnostica Uniq Pinp RiaCIN · Traditional | 05/04/2005SE |
| K042625 | Quikread CRP Calibrator SetJJY · Traditional | 11/18/2004SE |
| K042442 | Quickread System: Quickread CRP Kit, Model 06085; Quickread 101 Instrument, Model 06088…DCK · Special | 09/24/2004SE |
| K942286 | Diarlex Rota-AdenoLIQ · Traditional | 12/14/1994SE |
| K914892 | Saliva-StimEGD · Traditional | 09/02/1992SE |
| K904655 | PylorisetLYR · Traditional | 10/21/1991SE |
| K884147 | Immunochemical Determination of Immunoglobulin MDFT · Traditional | 10/27/1988SE |
| K884074 | Immunochemical Determination of Immunoglobulin GDAH · Traditional | 10/27/1988SE |
| K884075 | Immunochemical Determination of TransferrinDDG · Traditional | 10/19/1988SE |
Questions and answers
When was Rubella Virus Antigens & Controls cleared by the FDA?
Rubella Virus Antigens & Controls (K802937) received a 510(k) decision of Substantially Equivalent on December 31, 1980, 42 days after the submission was received.
What is the product code of K802937?
The FDA product code is GON – Antigen, Cf (Including Cf Control), Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.