Sanassay Ic Test
FDA 510(k) K860996 · Scientific Sales Intl., Inc.
510(k) numberK860996
Submission
- Device name
- Sanassay Ic Test
- Applicant
- Scientific Sales Intl., Inc.
Kalamazoo, MI, US - Received
- March 11, 1986
- Decision date
- March 30, 1987
- 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 |
| K864312 | Ic MicroassayDAK · Traditional | Diamedix Corp. | 01/09/1987SE |
| K862649 | Cytotech Cic Enzyme ImmunoassayDAK · Traditional | Cytotech, Inc. | 09/04/1986SE |
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Questions and answers
When was Sanassay Ic Test cleared by the FDA?
Sanassay Ic Test (K860996) received a 510(k) decision of Substantially Equivalent on March 30, 1987, 384 days after the submission was received.
What is the product code of K860996?
The FDA product code is DAK – Complement C1q, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.