Incstar HSV I/Ii Igg Fast Elisa Assay
FDA 510(k) K955362 · Incstar Corp.
510(k) numberK955362
Submission
- Device name
- Incstar HSV I/Ii Igg Fast Elisa Assay
- Applicant
- Incstar Corp.
Stillwater, MN, US - Received
- November 22, 1995
- Decision date
- July 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IGC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955363 | Incstar HSZ I/Ii Igg Elisa AssayIGC · Traditional | Incstar Corp. | 07/24/1996SE |
More from Incstar Corp.
| 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 |
| 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 HSV I/Ii Igg Fast Elisa Assay cleared by the FDA?
Incstar HSV I/Ii Igg Fast Elisa Assay (K955362) received a 510(k) decision of Substantially Equivalent on July 24, 1996, 245 days after the submission was received.
What is the product code of K955362?
The FDA product code is IGC – Formalin-Saline, a Class I (low risk) device regulated under 21 CFR 864.4010.