TINA-QUANT COMPLEMENT C4 TEST SYSTEM
FDA 510(k) clearance K012359 · decided 2001-11-29
Clearance details
- K-number
- K012359
- Device name
- TINA-QUANT COMPLEMENT C4 TEST SYSTEM
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-25
- Decision date
- 2001-11-29
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- DBI
- Device class
- 2
- Regulation number
- 866.5240
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SPAPLUS ANALYZER (K100455) | The Binding Site | 2010-09-03 |
| WAKO AUTOKIT C4 (K010325) | Wako Chemicals USA, Inc. | 2001-06-25 |
| RANDOX COMPLEMENT C4 (K000468) | Randox Laboratories, Ltd. | 2000-03-27 |
| DIMENSION C4 FLEX REAGENT CARTRIDGE (K994293) | Dade Behring, Inc. | 2000-03-01 |
| C4 MININEPH ANTISERUM (K981785) | The Binding Site, Ltd. | 1999-12-20 |
| K-ASSAY C4 (K993481) | Kamiya Biomedical Co. | 1999-11-29 |
| C4 (K983356) | Abbott Laboratories | 1998-11-04 |
| N-ASSAY TIA C4 TEST KIT (K964297) | Crestat Diagnostics, Inc. | 1997-07-14 |
| N-ASSAY TIA MULTI V-NL (K964300) | Crestat Diagnostics, Inc. | 1997-07-14 |
| OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT (K962582) | Olympus America, Inc. | 1996-10-18 |
| QUANTEX C4 (K962198) | Instrumentation Laboratory CO | 1996-09-26 |
| IL TEST COMPLEMENT 4 (K920010) | Instrumentation Laboratory CO | 1992-03-13 |
Recalls involving this device
No recalls on record reference this clearance.
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