Anti-Human Ciq Serum
FDA 510(k) K781022 · Icl Scientific
510(k) numberK781022
Submission
- Device name
- Anti-Human Ciq Serum
- Applicant
- Icl Scientific
Mchenry, IL, US - Received
- June 19, 1978
- Decision date
- August 14, 1978
- 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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|---|---|---|---|
| K031563 | Bindazyme CLQ Cic Eia KitDAK · Traditional | The Binding Site, Ltd. | 09/10/2003SE |
| K032254 | Ibl C1Q-CIC Cia TestDAK · Traditional | Ibl GmbH | 08/29/2003SE |
| K012576 | CIC-C1Q EiaDAK · Traditional | American Laboratory Products Co., Ltd. | 01/29/2002SE |
| K973203 | Thymostat Elisa for the Detection of Human Igg,M and a Anti-Rabbit Igg AntibodiesDAK · Traditional | Sangstat Medical Corp. | 09/30/1998SE |
| K972873 | Immustrip Hama IggDAK · Traditional | Immunomedics, Inc. | 03/17/1998SE |
| 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 |
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| K833761 | Therapeutic Drug ControlDKB · Traditional | 01/13/1984SE |
| K832823 | Enzymune-Test TSHJLW · Traditional | 10/14/1983SE |
| K831383 | Event-Test SlideJHJ · Traditional | 06/22/1983SE |
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| K822777 | Therapeutic Drug ControlDIF · Traditional | 10/08/1982SE |
| K822346 | Histimune Enzyme-Ana TestLJM · Traditional | 10/08/1982SE |
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Questions and answers
When was Anti-Human Ciq Serum cleared by the FDA?
Anti-Human Ciq Serum (K781022) received a 510(k) decision of Substantially Equivalent on August 14, 1978, 56 days after the submission was received.
What is the product code of K781022?
The FDA product code is DAK – Complement C1q, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.