Varicella Zoster Igg Clin-Elisa Test Kit
FDA 510(k) K900688 · Clinical Sciences, Inc.
510(k) numberK900688
Submission
- Device name
- Varicella Zoster Igg Clin-Elisa Test Kit
- Applicant
- Clinical Sciences, Inc.
Whippany, NJ, US - Received
- February 13, 1990
- Decision date
- May 15, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
| K961012 | VZV Igg Elisa Test SystemLFY · Traditional | Zeus Scientific, Inc. | 07/24/1996SE |
| K943843 | Varicelisa, ModificationLFY · Traditional | Biowhittaker Molecular Applications, Inc. | 03/14/1996SE |
More from Biowhittaker Molecular Applications, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883871 | Epstein-Barr Viral Capsid Antigen Igm #5590LSE · Traditional | 07/14/1989SE |
| K883870 | Epstein-Barr Viral Capsid Antigen Igg #4590LSE · Traditional | 07/14/1989SE |
| K891990 | Rubeola Igg Clin-Elisa Test System, Cat. #4600LJB · Traditional | 06/15/1989SE |
| K883601 | Epstein-Barr Virus (EBNA-1) Igm Cata. #5550LLM · Traditional | 05/11/1989SE |
| K883600 | Epstein-Barr Virus (EBNA-1) Igg Cata. #4550LLM · Traditional | 05/11/1989SE |
| K874594 | Toxoplasma Igm Clin-Elisa(Tm) Cat # 5560LGD · Traditional | 03/07/1988SE |
| K872942 | Igm CMV Clin-Elisa(Tm) Test System Number: 5530LKQ · Traditional | 01/11/1988SE |
| K860145 | Rubella Elisa Test System Catalog Number: 4540LFX · Traditional | 07/14/1986SE |
| K860773 | Toxoplasma Igg Clin-Elisa Test Kit Cat. No. 4560LGD · Traditional | 05/23/1986SE |
| K854666 | Cytomegalovirus (CMV) Elisa Test Sys. Cat. NO:4530GQI · Traditional | 02/05/1986SE |
Questions and answers
When was Varicella Zoster Igg Clin-Elisa Test Kit cleared by the FDA?
Varicella Zoster Igg Clin-Elisa Test Kit (K900688) received a 510(k) decision of Substantially Equivalent on May 15, 1990, 91 days after the submission was received.
What is the product code of K900688?
The FDA product code is LFY – Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster, a Class II (moderate risk) device regulated under 21 CFR 866.3900.