VZV Igg Elisa Test System
FDA 510(k) K961012 · Zeus Scientific, Inc.
510(k) numberK961012
Submission
- Device name
- VZV Igg Elisa Test System
- Applicant
- Zeus Scientific, Inc.
Branchburg, NJ, US - Received
- March 13, 1996
- Decision date
- July 24, 1996
- 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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|---|---|---|---|
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HTLFY · Traditional | DiaSorin, Inc. | 10/27/2023SE |
| K150375 | LIAISON VZV IgG, LIAISON Control VZV IgGLFY · Special | DiaSorin, Inc. | 03/11/2015SE |
| 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 |
| K051484 | Zeus Scientific, Inc., Athena Multi-Lyte MMRV Igg Test System.LFY · Traditional | Zeus Scientific, Inc. | 12/05/2005SE |
| 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 |
| 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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| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFineKTL · Traditional | 08/31/2023SE |
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| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFineDHN · Traditional | 04/29/2022SE |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
Questions and answers
When was VZV Igg Elisa Test System cleared by the FDA?
VZV Igg Elisa Test System (K961012) received a 510(k) decision of Substantially Equivalent on July 24, 1996, 133 days after the submission was received.
What is the product code of K961012?
The FDA product code is LFY – Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster, a Class II (moderate risk) device regulated under 21 CFR 866.3900.