Biostar* Reads* Immune Complex Assay Kit
FDA 510(k) K861499 · Biostar Medical Products, Inc.
510(k) numberK861499
Submission
- Device name
- Biostar* Reads* Immune Complex Assay Kit
- Applicant
- Biostar Medical Products, Inc.
Denver, CO, US - Received
- April 23, 1986
- Decision date
- June 20, 1986
- 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 |
More from Diamedix Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K893896 | Quantitative Assay for Det. of Igg Igm Anti-DsdnaLKJ · Traditional | 07/14/1989SE |
| K893897 | Semi-Quantitative Assay for Det. of Igg and IgmLKJ · Traditional | 06/23/1989SE |
| K863238 | Reads RF Test Kit for Igm Rheumatoid FactorDHR · Traditional | 10/08/1986SE |
| K853697 | Biostar Re-A-Ds Immune Complex Assay KitDAK · Traditional | 12/16/1985SE |
Questions and answers
When was Biostar* Reads* Immune Complex Assay Kit cleared by the FDA?
Biostar* Reads* Immune Complex Assay Kit (K861499) received a 510(k) decision of Substantially Equivalent on June 20, 1986, 58 days after the submission was received.
What is the product code of K861499?
The FDA product code is DAK – Complement C1q, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.