Complement Activation Eia Test System (Cae)
FDA 510(k) K951639 · Incstar Corp.
510(k) numberK951639
Submission
- Device name
- Complement Activation Eia Test System (Cae)
- Applicant
- Incstar Corp.
Stillwater, MN, US - Received
- April 10, 1995
- Decision date
- October 13, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DAE – Complement C9, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5240
- Specialty
- Immunology
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|---|---|---|---|
| K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 CalibratorDAE · Traditional | The Binding Site Group , Ltd. | 08/28/2015SE |
| K113349 | Human CH50 Reagent Pack for Use on the Spaplus, Human CH50 Calibrator Set for Use on the…DAE · Traditional | The Binding Site Group , Ltd. | 07/11/2012SE |
| K992488 | Total Haemolytic Complement Rid KitDAE · Traditional | The Binding Site, Ltd. | 09/17/1999SE |
| K974111 | Quidel CH50 Eq EiaDAE · Traditional | Quidel Corp. | 07/29/1998SE |
| K954145 | Wako Autokit CH50DAE · Traditional | Wako Chemicals USA, Inc. | 12/18/1995SE |
More from Wako Chemicals USA, 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 |
| K955361 | Incstar Cytomegalovirus Igg Elisa AssayLFZ · Traditional | 07/22/1996SE |
Questions and answers
When was Complement Activation Eia Test System (Cae) cleared by the FDA?
Complement Activation Eia Test System (Cae) (K951639) received a 510(k) decision of Substantially Equivalent on October 13, 1995, 186 days after the submission was received.
What is the product code of K951639?
The FDA product code is DAE – Complement C9, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.