Scrippsystem C4 Rid Kit
FDA 510(k) K810502 · Scripps-Miles, Inc.
510(k) numberK810502
Submission
- Device name
- Scrippsystem C4 Rid Kit
- Applicant
- Scripps-Miles, Inc.
Mchenry, IL, US - Received
- February 24, 1981
- Decision date
- April 8, 1981
- 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 |
|---|---|---|
| K812453 | Scrippsystem Immunoglobin Rid KitDEW · Traditional | 09/23/1981SE |
| K812328 | Scrippsystem Nephelometric Antisera KitDEW · Traditional | 09/08/1981SE |
| K811714 | HEP-2-CRITHIDIA Luciliae Ana Test KitDHN · Traditional | 07/10/1981SE |
| K811433 | Scrippsera Complement Control SeraDHL · Traditional | 06/16/1981SE |
| K810501 | Scrippsystem C3 Rid KitCZW · Traditional | 04/08/1981SE |
| K810221 | Scrippsera Theumatoid Factor Refer. CNTLDHR · Traditional | 02/09/1981SE |
| K810141 | Scrippsystem Rheumatoid Factor Latex KitDHR · Traditional | 02/09/1981SE |
| K810081 | Scrippsera Ana Reference Control SeraDHN · Traditional | 02/09/1981SE |
Questions and answers
When was Scrippsystem C4 Rid Kit cleared by the FDA?
Scrippsystem C4 Rid Kit (K810502) received a 510(k) decision of Substantially Equivalent on April 8, 1981, 43 days after the submission was received.
What is the product code of K810502?
The FDA product code is DBI – Complement C4, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.