Virogen Rubella Slide Test
FDA 510(k) K844435 · Armkel, LLC
510(k) numberK844435
Submission
- Device name
- Virogen Rubella Slide Test
- Applicant
- Armkel, LLC
Cranbury, NJ, US - Received
- November 16, 1984
- Decision date
- May 20, 1985
- 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 |
| K861881 | Rubalex (Revised Version)LQN · Traditional | Orion Corp. | 06/04/1986SE |
More from Orion Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K040866 | First Response One-Step Digital Pregnancy TestLCX · Traditional | 10/19/2004SE |
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| K023405 | Trojan Mint Tingle Brand Latex CondomsHIS · Abbreviated | 12/16/2002SE |
| K013433 | Trojan Passion Berry GelNUC · Traditional | 03/05/2002SE |
| K013614 | Trojan Crystal Clear LiquidNUC · Traditional | 02/01/2002SE |
| K001212 | Trojan Extra Large Latex CondomHIS · Special | 05/09/2000SE |
| K000748 | Trojan Latex Condom with Male Genital Desensitizer LubricantHIS · Special | 04/06/2000SE |
| K992232 | First Response 1-STEP PregnancyLCX · Traditional | 12/21/1999SE |
| K973352 | Brand Name *1-STEP PregnancyLCX · Traditional | 10/27/1997SE |
| K973310 | Tbd* One-Step Ovulation Predictor TestCEP · Traditional | 10/27/1997SE |
Questions and answers
When was Virogen Rubella Slide Test cleared by the FDA?
Virogen Rubella Slide Test (K844435) received a 510(k) decision of Substantially Equivalent on May 20, 1985, 185 days after the submission was received.
What is the product code of K844435?
The FDA product code is LQN – Latex Agglutination Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.