Gilford C4 Complement Reagent
FDA 510(k) K853468 · Gilford
510(k) numberK853468
Submission
- Device name
- Gilford C4 Complement Reagent
- Applicant
- Gilford
Oberlin, OH, US - Received
- August 19, 1985
- Decision date
- September 16, 1985
- 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 |
|---|---|---|
| K853469 | Gilford Immunoglobulin M ReagentDFT · Traditional | 09/16/1985SE |
| K853467 | Gilford Immunoglobulin a ReagentCZP · Traditional | 09/16/1985SE |
| K853466 | Gilford C3 Complement ReagentCZW · Traditional | 09/16/1985SE |
| K853465 | Gilford Immunoglobulin G ReagentDEW · Traditional | 09/16/1985SE |
| K851202 | Gilford Tri-Level Assayed Immunology ControlDAK · Traditional | 04/29/1985SE |
| K842500 | Data Mgmt. SystemJJE · Traditional | 08/16/1984SE |
| K840120 | AdvantageJJE · Traditional | 03/23/1984SE |
| K833067 | Impact 400 #1447X2JJE · Traditional | 12/08/1983SE |
| K812787 | Eia RubellaLFX · Traditional | 11/27/1981SE |
Questions and answers
When was Gilford C4 Complement Reagent cleared by the FDA?
Gilford C4 Complement Reagent (K853468) received a 510(k) decision of Substantially Equivalent on September 16, 1985, 28 days after the submission was received.
What is the product code of K853468?
The FDA product code is DBI – Complement C4, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.