Serum Complement Activity Test-Scat
FDA 510(k) K841541 · Collaborative Research, Inc.
510(k) numberK841541
Submission
- Device name
- Serum Complement Activity Test-Scat
- Applicant
- Collaborative Research, Inc.
Mchenry, IL, US - Received
- April 16, 1984
- Decision date
- June 1, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DAK – Complement C1q, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5240
- Specialty
- Immunology
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| K951968 | Human C1Q Radial Immunodiffusion KitDAK · Traditional | Kent Laboratories, Inc. | 05/30/1995SE |
| K914388 | C1 Rid KitDAK · Traditional | The Binding Site, Ltd. | 10/28/1991SE |
| K882829 | Circulating Immune Complexes ControlsDAK · Traditional | Cytotech, Inc. | 08/04/1988SE |
| K860996 | Sanassay Ic TestDAK · Traditional | Scientific Sales Intl., Inc. | 03/30/1987SE |
| K864312 | Ic MicroassayDAK · Traditional | Diamedix Corp. | 01/09/1987SE |
More from Diamedix Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K840241 | Thyroxine EmiaKLI · Traditional | 03/30/1984SE |
Questions and answers
When was Serum Complement Activity Test-Scat cleared by the FDA?
Serum Complement Activity Test-Scat (K841541) received a 510(k) decision of Substantially Equivalent on June 1, 1984, 46 days after the submission was received.
What is the product code of K841541?
The FDA product code is DAK – Complement C1q, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.