C4
FDA 510(k) clearance K983356 · decided 1998-11-04
Clearance details
- K-number
- K983356
- Device name
- C4
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1998-09-24
- Decision date
- 1998-11-04
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- DBI
- Device class
- 2
- Regulation number
- 866.5240
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Irving, TX, 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 |
| TINA-QUANT COMPLEMENT C4 TEST SYSTEM (K012359) | Roche Diagnostics Corp. | 2001-11-29 |
| 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 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |