CIC-C1Q Eia
FDA 510(k) K012576 · American Laboratory Products Co., Ltd.
510(k) numberK012576
Submission
- Device name
- CIC-C1Q Eia
- Applicant
- American Laboratory Products Co., Ltd.
Windham, NH, US - Received
- August 9, 2001
- Decision date
- January 29, 2002
- 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
Other 510(k)s with product code DAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K862649 | Cytotech Cic Enzyme ImmunoassayDAK · Traditional | Cytotech, Inc. | 09/04/1986SE |
More from Cytotech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K011415 | Alpco Milenia Anti-Tg EiaJZO · Traditional | 05/30/2001SE |
| K011201 | Alpco Milenia Anti-Tpo ElisaJZO · Traditional | 05/24/2001SE |
| K974702 | Orgentec ANTI-PR3 (C-Anca) ElisaMOB · Traditional | 02/17/1998SE |
| K974701 | Orgentec Anti-Mpo (P-Anca) ElisaMOB · Traditional | 02/17/1998SE |
| K972190 | Thyroglobulin Assay SystemJZO · Traditional | 07/14/1997SE |
| K970932 | Orgentec Micro-Albumin Eia AssayJIR · Traditional | 04/08/1997SE |
| K962062 | Orgentec Anti-Sm ElisaLJM · Traditional | 11/18/1996SE |
| K962057 | Orgentec Anti-Rnp/Sm ElisaLJM · Traditional | 11/18/1996SE |
| K962055 | Orgentec Anti-Scl 70 ElisaLJM · Traditional | 11/15/1996SE |
| K962054 | Orgentec Anti-Ss-A(Ro) ElisaLJM · Traditional | 11/15/1996SE |
Questions and answers
When was CIC-C1Q Eia cleared by the FDA?
CIC-C1Q Eia (K012576) received a 510(k) decision of Substantially Equivalent on January 29, 2002, 173 days after the submission was received.
What is the product code of K012576?
The FDA product code is DAK – Complement C1q, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.