Incstar Rubella Igg Elisa Assay
FDA 510(k) K960367 · Incstar Corp.
510(k) numberK960367
Submission
- Device name
- Incstar Rubella Igg Elisa Assay
- Applicant
- Incstar Corp.
Stillwater, MN, US - Received
- January 25, 1996
- Decision date
- October 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFX – Enzyme Linked Immunoabsorbent Assay, Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
Other 510(k)s with product code LFX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250588 | Access Rubella IgGLFX · Traditional | Beckman Coulter, Inc. | 11/17/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | Abbott Laboratories | 06/20/2025SE |
| K122397 | Liaison Rubella Igm, Liaison Control Rubella IgmLFX · Traditional | DiaSorin, Inc. | 09/06/2012SE |
| K093101 | Mago 4SLFX · Traditional | Diamedix Corp. | 01/21/2011SE |
| K092587 | Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection SystemLFX · Traditional | Bio-Rad Laboratories | 12/03/2010SE |
| K092322 | Elecsys Rubella Igm ImmunoassayLFX · Traditional | Roche Diagnostics | 03/12/2010SE |
| K080766 | Vidas Rub IggLFX · Traditional | bioMerieux, Inc. | 12/23/2008SE |
| K072617 | Elecsys Rubella Igg ImmunoassayLFX · Traditional | Roche Diagnostics Corp. | 12/05/2008SE |
| K073390 | Diasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg Tri-ControlsLFX · Traditional | DiaSorin, Inc. | 11/21/2008SE |
| K063186 | Athena Multi-Lyte Rubella Igg Test SystemLFX · Traditional | Zeus Scientific, Inc. | 03/21/2007SE |
More from Zeus Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K963289 | Incstar Toxoplasma Igm Capture Elisa AssayLGD · Traditional | 05/01/1997SE |
| K963297 | Incstar Toxoplasma Igg Fast Elisa Assay (CAT.#7560)LGD · Traditional | 12/16/1996SE |
| K963296 | Incstar Toxoplasma Igg Alisa Assay (CAT.#7565)LGD · Traditional | 12/16/1996SE |
| K960358 | Incstar Rubella Igg Fast Elisa AssayLFX · Traditional | 10/24/1996SE |
| K960434 | Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530LFZ · Traditional | 10/17/1996SE |
| K953567 | Incstar 25-HYDROXYVITMIN D 1251 RiaMRG · Traditional | 09/25/1996SE |
| K955363 | Incstar HSZ I/Ii Igg Elisa AssayIGC · Traditional | 07/24/1996SE |
| K955362 | Incstar HSV I/Ii Igg Fast Elisa AssayIGC · Traditional | 07/24/1996SE |
| K955361 | Incstar Cytomegalovirus Igg Elisa AssayLFZ · Traditional | 07/22/1996SE |
| K955360 | Incstar Cytomegalovirus Igg Fast Elisa AssayLFZ · Traditional | 07/22/1996SE |
Questions and answers
When was Incstar Rubella Igg Elisa Assay cleared by the FDA?
Incstar Rubella Igg Elisa Assay (K960367) received a 510(k) decision of Substantially Equivalent on October 24, 1996, 273 days after the submission was received.
What is the product code of K960367?
The FDA product code is LFX – Enzyme Linked Immunoabsorbent Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.