Colorslider Rubella
FDA 510(k) K952544 · Seradyn, Inc.
510(k) numberK952544
Submission
- Device name
- Colorslider Rubella
- Applicant
- Seradyn, Inc.
Indianapolis, IN, US - Received
- June 2, 1995
- Decision date
- January 17, 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
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| 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 |
| 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 |
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Questions and answers
When was Colorslider Rubella cleared by the FDA?
Colorslider Rubella (K952544) received a 510(k) decision of Substantially Equivalent on January 17, 1996, 229 days after the submission was received.
What is the product code of K952544?
The FDA product code is LQN – Latex Agglutination Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.