Raichem Spia C4 Reagent
FDA 510(k) K911899 · Reagents Applications, Inc.
510(k) numberK911899
Submission
- Device name
- Raichem Spia C4 Reagent
- Applicant
- Reagents Applications, Inc.
San Diego, CA, US - Received
- April 26, 1991
- Decision date
- May 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K982056 | Raichem CO2 ReagentKHS · Special | 06/24/1998SE |
| K972853 | Cholesterol Rapid Liquid ReagentCHH · Traditional | 09/24/1997SE |
| K922904 | Rai-Trol Fructosamine Serum Controls I and IIJJX · Traditional | 07/30/1992SE |
| K915191 | Rai-Trol Elevated Lipids ControlJJY · Traditional | 12/18/1991SE |
| K913398 | Raichem(Tm) Creatine Kinase-Mb ReagentCGS · Traditional | 09/25/1991SE |
| K911900 | Raichem Spia C3 ReagentCZW · Traditional | 05/09/1991SE |
| K911898 | Raichem(Tm) Spia(Tm) Haptoglobin ReagentDAD · Traditional | 05/08/1991SE |
| K905085 | Raichem GGT ReagentJQB · Traditional | 12/20/1990SE |
| K905084 | Raichem Creatine Kinase Reagent, Optimized UVCGS · Traditional | 12/20/1990SE |
| K904175 | Raichem (TM) Spia (TM) - Acid Glycoprotein ReagentLKL · Traditional | 11/13/1990SE |
Questions and answers
When was Raichem Spia C4 Reagent cleared by the FDA?
Raichem Spia C4 Reagent (K911899) received a 510(k) decision of Substantially Equivalent on May 9, 1991, 13 days after the submission was received.
What is the product code of K911899?
The FDA product code is DBI – Complement C4, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.