Rubalex (Revised Version)
FDA 510(k) K861881 · Orion Corp.
510(k) numberK861881
Submission
- Device name
- Rubalex (Revised Version)
- Applicant
- Orion Corp.
20101 Turku, FI - Received
- May 8, 1986
- Decision date
- June 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQN – Latex Agglutination Assay, Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
Other 510(k)s with product code LQN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031490 | RubellacolLQN · Traditional | Immunostics Inc., | 07/16/2003SE |
| K970931 | Copalis Torc Total Antibody AssayLQN · Traditional | Sienna Biotech, Inc. | 04/24/1997SE |
| K961784 | Copalis One Immunoassay System/Toxoplasma Gondii/Rubella/Cmv Total Antibody AssaysLQN · Traditional | Sienna Biotech, Inc. | 10/31/1996SE |
| K954920 | Murex Rub-ExLQN · Traditional | Murex Diagnostics, Inc. | 08/21/1996SE |
| K952544 | Colorslider RubellaLQN · Traditional | Seradyn, Inc. | 01/17/1996SE |
| K912391 | Rubalex, ModificationLQN · Traditional | Orion Corp. | 05/04/1992SE |
| K901637 | Resubmitted Modified RubalexLQN · Traditional | Orion Corp. | 04/26/1990SE |
| K896433 | Modified RubagenLQN · Traditional | Biokit USA, Inc. | 11/29/1989SE |
| K893755 | RubagenLQN · Traditional | Biokit USA, Inc. | 08/21/1989SE |
| K852788 | RubalexLQN · Traditional | Orion Corp. | 03/12/1986SE |
More from Orion Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K912391 | Rubalex, ModificationLQN · Traditional | 05/04/1992SE |
| K901637 | Resubmitted Modified RubalexLQN · Traditional | 04/26/1990SE |
| K884650 | Resubmitted ScanoraIZF · Traditional | 03/16/1989SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | 03/02/1989SE |
| K881506 | Mamex DC Mag MG12IZH · Traditional | 06/10/1988SE |
| K881505 | Mamex DC MG11IZH · Traditional | 06/10/1988SE |
| K874040 | Mamex DC S SL10/MG14IZH · Traditional | 11/23/1987SE |
| K872744 | Modified Chlamyset AntigenLJP · Traditional | 09/22/1987SE |
| K872301 | Dentocult-Sm Culture-PaddleJSI · Traditional | 09/11/1987SE |
| K864457 | Chlamyset Antibody EiaLJC · Traditional | 09/11/1987SE |
Questions and answers
When was Rubalex (Revised Version) cleared by the FDA?
Rubalex (Revised Version) (K861881) received a 510(k) decision of Substantially Equivalent on June 4, 1986, 27 days after the submission was received.
What is the product code of K861881?
The FDA product code is LQN – Latex Agglutination Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.