Plates for Human C4 Complement
FDA 510(k) K772002 · G.D. Searle and Co.
510(k) numberK772002
Submission
- Device name
- Plates for Human C4 Complement
- Applicant
- G.D. Searle and Co.
Mchenry, IL, US - Received
- October 21, 1977
- Decision date
- November 2, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DBI – Complement C4, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5240
- Specialty
- Immunology
Other 510(k)s with product code DBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100455 | Spaplus AnalyzerDBI · Traditional | The Binding Site | 09/03/2010SE |
| K012359 | Tina-Quant Complement C4 Test SystemDBI · Traditional | Roche Diagnostics Corp. | 11/29/2001SE |
| K010325 | Wako Autokit C4DBI · Traditional | Wako Chemicals USA, Inc. | 06/25/2001SE |
| K000468 | Randox Complement C4DBI · Traditional | Randox Laboratories, Ltd. | 03/27/2000SE |
| K994293 | Dimension C4 Flex Reagent CartridgeDBI · Traditional | Dade Behring, Inc. | 03/01/2000SE |
| K981785 | C4 Minineph AntiserumDBI · Traditional | The Binding Site, Ltd. | 12/20/1999SE |
| K993481 | K-Assay C4DBI · Traditional | Kamiya Biomedical Co. | 11/29/1999SE |
| K983356 | C4DBI · Traditional | Abbott Laboratories | 11/04/1998SE |
| K964300 | N-Assay Tia Multi V-NlDBI · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K964297 | N-Assay Tia C4 Test KitDBI · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
More from Crestat Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K821159 | In-Line Oxygen Monitoring SystemDRY · Traditional | 05/25/1982SE |
| K811068 | Bypass CoilKPY · Traditional | 05/27/1981SE |
| K811071 | Venous Oxygen ProbeCCE · Traditional | 05/05/1981SE |
| K803238 | Intravascular CatheterFOZ · Traditional | 04/23/1981SE |
| K810630 | Silicone Elastomer Coated Latex FoleyKOD · Traditional | 03/31/1981SE |
| K810131 | Administration SetFPD · Traditional | 02/26/1981SE |
| K802485 | Searle Vascular LoopsKDC · Traditional | 02/12/1981SE |
| K801805 | Metronidazole DiscsJWY · Traditional | 02/10/1981SE |
| K810112 | SWR Disposable Prep RazorKDC · Traditional | 02/04/1981SE |
| K802280 | White Knight Drape SealKKX · Traditional | 10/10/1980SE |
Questions and answers
When was Plates for Human C4 Complement cleared by the FDA?
Plates for Human C4 Complement (K772002) received a 510(k) decision of Substantially Equivalent on November 2, 1977, 12 days after the submission was received.
What is the product code of K772002?
The FDA product code is DBI – Complement C4, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.