The Aptus (Automated) Application of the VZV Igg Elisa Test System
FDA 510(k) K984181 · Zeus Scientific, Inc.
510(k) numberK984181
Submission
- Device name
- The Aptus (Automated) Application of the VZV Igg Elisa Test System
- Applicant
- Zeus Scientific, Inc.
Branchburg, NJ, US - Received
- November 23, 1998
- Decision date
- January 22, 1999
- 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 |
| 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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| 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 The Aptus (Automated) Application of the VZV Igg Elisa Test System cleared by the FDA?
The Aptus (Automated) Application of the VZV Igg Elisa Test System (K984181) received a 510(k) decision of Substantially Equivalent on January 22, 1999, 60 days after the submission was received.
What is the product code of K984181?
The FDA product code is LFY – Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster, a Class II (moderate risk) device regulated under 21 CFR 866.3900.