Varicelisa, Modification
FDA 510(k) K943843 · Biowhittaker Molecular Applications, Inc.
510(k) numberK943843
Submission
- Device name
- Varicelisa, Modification
- Applicant
- Biowhittaker Molecular Applications, Inc.
Walkersville, MD, US - Received
- July 28, 1994
- Decision date
- March 14, 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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| 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 |
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| 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 |
| K941046 | VZV Igg Elisa TestLFY · Traditional | Gull Laboratories, Inc. | 08/24/1995SE |
More from Gull Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942361 | WhitsoftJJQ · Traditional | 04/04/1995SE |
| K942250 | Biowhittaker Cartridge Software for EIA-400 Plate ReaderJJQ · Traditional | 04/04/1995SE |
| K942245 | Biowhittaker 2001 Microplate Reader FirmwareJJQ · Traditional | 04/03/1995SE |
| K925209 | Mumps StatLJY · Traditional | 10/14/1994SE |
| K935618 | Specimen Transport MediumJSM · Traditional | 04/21/1994SE |
| K932679 | Rheumelisa II Histone Antibody Test KitLKJ · Traditional | 08/23/1993SE |
| K930757 | Rheumelisa II JO-1 Antibody Test KitLLL · Traditional | 03/26/1993SE |
| K930130 | Rheumelisa II SCL-70 Antibody Test KitLLL · Traditional | 03/23/1993SE |
| K920753 | RF Stat Igm Test KitDHR · Traditional | 03/30/1992SE |
Questions and answers
When was Varicelisa, Modification cleared by the FDA?
Varicelisa, Modification (K943843) received a 510(k) decision of Substantially Equivalent on March 14, 1996, 595 days after the submission was received.
What is the product code of K943843?
The FDA product code is LFY – Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster, a Class II (moderate risk) device regulated under 21 CFR 866.3900.