Murex Rub-Ex
FDA 510(k) K954920 · Murex Diagnostics, Inc.
510(k) numberK954920
Submission
- Device name
- Murex Rub-Ex
- Applicant
- Murex Diagnostics, Inc.
Norcross, GA, US - Received
- October 26, 1995
- Decision date
- August 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K861881 | Rubalex (Revised Version)LQN · Traditional | Orion Corp. | 06/04/1986SE |
| K852788 | RubalexLQN · Traditional | Orion Corp. | 03/12/1986SE |
More from Orion Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K962028 | Wellcolex E-Coli OI57 ZC60GNA · Traditional | 11/01/1996SE |
Questions and answers
When was Murex Rub-Ex cleared by the FDA?
Murex Rub-Ex (K954920) received a 510(k) decision of Substantially Equivalent on August 21, 1996, 300 days after the submission was received.
What is the product code of K954920?
The FDA product code is LQN – Latex Agglutination Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.