Gilford C3 Complement Reagent
FDA 510(k) K853466 · Gilford
510(k) numberK853466
Submission
- Device name
- Gilford C3 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
- CZW – Complement C3, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5240
- Specialty
- Immunology
Other 510(k)s with product code CZW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100179 | SpaplusCZW · Traditional | The Binding Site Group , Ltd. | 08/13/2010SE |
| K063150 | Complement C3 and C4, Specical Calibrator and Specitrol Control and High ControlCZW · Traditional | Thermo Electron OY | 03/19/2007SE |
| K061852 | Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low…CZW · Traditional | Dade Behring, Inc. | 09/22/2006SE |
| K050665 | N Antisera to Human Complement Factors (C3C, C4)CZW · Traditional | Dade Behring, Inc. | 05/02/2005SE |
| K042494 | Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance…CZW · Traditional | Ortho-Clinical Diagnostics | 10/19/2004SE |
| K032796 | Ibl C3D-CIC Eia TestCZW · Traditional | Ibl GmbH | 01/13/2004SE |
| K032035 | Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4)…CZW · Traditional | Beckman Coulter, Inc. | 08/07/2003SE |
| K012361 | Tina-Quant Complement C3C Test SystemCZW · Traditional | Roche Diagnostics Corp. | 11/29/2001SE |
| K010326 | Wako Autokit C3CZW · Traditional | Wako Chemicals USA, Inc. | 06/25/2001SE |
| K000469 | Randox Complement C3CZW · Traditional | Randox Laboratories, Ltd. | 03/27/2000SE |
More from Randox Laboratories, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K853469 | Gilford Immunoglobulin M ReagentDFT · Traditional | 09/16/1985SE |
| K853468 | Gilford C4 Complement ReagentDBI · Traditional | 09/16/1985SE |
| K853467 | Gilford Immunoglobulin a ReagentCZP · 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 C3 Complement Reagent cleared by the FDA?
Gilford C3 Complement Reagent (K853466) 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 K853466?
The FDA product code is CZW – Complement C3, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.