Tina-Quant(R) (a) C4
FDA 510(k) K870931 · Boehringer Mannheim Corp.
510(k) numberK870931
Submission
- Device name
- Tina-Quant(R) (a) C4
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- March 9, 1987
- Decision date
- March 24, 1987
- 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 |
|---|---|---|
| K984326 | Elecys Ige AssayJHR · Traditional | 02/08/1999SE |
| K983047 | Accu-Chek HQ SystemLFR · Traditional | 02/05/1999SE |
| K984419 | Elecsys Ige CalcheckJJY · Traditional | 02/02/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
Questions and answers
When was Tina-Quant(R) (a) C4 cleared by the FDA?
Tina-Quant(R) (a) C4 (K870931) received a 510(k) decision of Substantially Equivalent on March 24, 1987, 15 days after the submission was received.
What is the product code of K870931?
The FDA product code is DBI – Complement C4, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.