C1 Rid Kit
FDA 510(k) K914388 · The Binding Site, Ltd.
510(k) numberK914388
Submission
- Device name
- C1 Rid Kit
- Applicant
- The Binding Site, Ltd.
Los Angeles, CA, US - Received
- October 1, 1991
- Decision date
- October 28, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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|---|---|---|---|
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| K032254 | Ibl C1Q-CIC Cia TestDAK · Traditional | Ibl GmbH | 08/29/2003SE |
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| K951968 | Human C1Q Radial Immunodiffusion KitDAK · Traditional | Kent Laboratories, Inc. | 05/30/1995SE |
| 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 |
| K862649 | Cytotech Cic Enzyme ImmunoassayDAK · Traditional | Cytotech, Inc. | 09/04/1986SE |
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Questions and answers
When was C1 Rid Kit cleared by the FDA?
C1 Rid Kit (K914388) received a 510(k) decision of Substantially Equivalent on October 28, 1991, 27 days after the submission was received.
What is the product code of K914388?
The FDA product code is DAK – Complement C1q, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.