Zeus Scientific, Inc., Athena Multi-Lyte MMRV Igg Test System.
FDA 510(k) K051484 · Zeus Scientific, Inc.
510(k) numberK051484
Submission
- Device name
- Zeus Scientific, Inc., Athena Multi-Lyte MMRV Igg Test System.
- Applicant
- Zeus Scientific, Inc.
Branchburg, NJ, US - Received
- June 6, 2005
- Decision date
- December 5, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LFY – Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3900
- Specialty
- Microbiology
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| K070317 | Zeus Scientific, Inc VZV Igm Elisa Test SystemLFY · Traditional | Zeus Scientific, Inc. | 07/05/2007SE |
| K061820 | Diasorin Liaison VZV IggLFY · Traditional | DiaSorin, Inc. | 02/26/2007SE |
| K984181 | The Aptus (Automated) Application of the VZV Igg Elisa Test SystemLFY · Traditional | Zeus Scientific, Inc. | 01/22/1999SE |
| K981867 | Is-Vzu Igg Test SystemLFY · Traditional | Diamedix Corp. | 09/28/1998SE |
| K972295 | Seraquest VZV IggLFY · Traditional | Quest Intl., Inc. | 11/05/1997SE |
| K961012 | VZV Igg Elisa Test SystemLFY · Traditional | Zeus Scientific, Inc. | 07/24/1996SE |
| K943843 | Varicelisa, ModificationLFY · Traditional | Biowhittaker Molecular Applications, Inc. | 03/14/1996SE |
| K941046 | VZV Igg Elisa TestLFY · Traditional | Gull Laboratories, Inc. | 08/24/1995SE |
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Questions and answers
When was Zeus Scientific, Inc., Athena Multi-Lyte MMRV Igg Test System. cleared by the FDA?
Zeus Scientific, Inc., Athena Multi-Lyte MMRV Igg Test System. (K051484) received a 510(k) decision of Substantially Equivalent on December 5, 2005, 182 days after the submission was received.
What is the product code of K051484?
The FDA product code is LFY – Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster, a Class II (moderate risk) device regulated under 21 CFR 866.3900.