Incstar Cytomegalovirus Igg Elisa Assay
FDA 510(k) K955361 · Incstar Corp.
510(k) numberK955361
Submission
- Device name
- Incstar Cytomegalovirus Igg Elisa Assay
- Applicant
- Incstar Corp.
Stillwater, MN, US - Received
- November 22, 1995
- Decision date
- July 22, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
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| K040290 | Diasorin Liaison CMV Igm/IggLFZ · Traditional | Diasorin S.P.A | 06/01/2005SE |
| K993952 | Immulite 2000 CMV Igg, Model L2KCV2, L2KCV6LFZ · Special | Diagnostic Products Corp. | 12/16/1999SE |
| K982485 | Seraquest CMV IgmLFZ · Traditional | Quest Intl., Inc. | 01/13/1999SE |
More from Quest Intl., 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 |
| K960367 | Incstar Rubella Igg Elisa AssayLFX · Traditional | 10/24/1996SE |
| 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 |
| K955360 | Incstar Cytomegalovirus Igg Fast Elisa AssayLFZ · Traditional | 07/22/1996SE |
Questions and answers
When was Incstar Cytomegalovirus Igg Elisa Assay cleared by the FDA?
Incstar Cytomegalovirus Igg Elisa Assay (K955361) received a 510(k) decision of Substantially Equivalent on July 22, 1996, 243 days after the submission was received.
What is the product code of K955361?
The FDA product code is LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.