510(k) K063150
- Device
- COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
- Applicant
- THERMO ELECTRON OY
- 510(k) number
- K063150
- Product code
- CZW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-03-19
- Date received
- 2006-10-16
- Regulation
- 866.5240
- Classification name
- Complement C3, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAIVI SORMUNEN
- Address
- Ratastie 2 P.O. Box 100 Vantaa FI FIN-01621 FIN-01621
FDA Registration Numbers#
- 9614373
- 2517506
- 3016438761
- 1000403749
- 3005333358
- 3006198300
- 3004493545
- 9680746
- 1319808
- 3000308930
- 3013059683
- 3002809144
- 3010825766
- 3012471076
- 3002642396
- 3005094123
- 9610126
- 3003795116
- 9610806
- 3019906
- 1181121
- 2084025
- 3003423869
- 3012963943
- 2250051
- 3009189893
- 2050012
- 9610099
- 9610529
- 2050010
- 2432235
- 1319681
Source Documents#
Other 510(k) Records For Product Code CZW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100179 | SPAPLUS | The Binding Site Group , Ltd. | 2010-08-13 |
| K061852 | DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH | Dade Behring, Inc. | 2006-09-22 |
| K050665 | N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) | Dade Behring, Inc. | 2005-05-02 |
| K042494 | VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III | Ortho-Clinical Diagnostics | 2004-10-19 |
| K032796 | IBL C3D-CIC EIA TEST | Ibl GmbH | 2004-01-13 |
| K032035 | SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI | Beckman Coulter, Inc. | 2003-08-07 |
| K012361 | TINA-QUANT COMPLEMENT C3C TEST SYSTEM | Roche Diagnostics Corp. | 2001-11-29 |
| K010326 | WAKO AUTOKIT C3 | Wako Chemicals USA, Inc. | 2001-06-25 |
| K000469 | RANDOX COMPLEMENT C3 | Randox Laboratories, Ltd. | 2000-03-27 |
| K994296 | DIMENSION C3 FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2000-03-01 |
| K981783 | C3 MININEPH ANTISERUM | The Binding Site, Ltd. | 1999-12-20 |
| K993437 | K-ASSAY C3 | Kamiya Biomedical Co. | 1999-11-24 |
| K991907 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | Bayer Corp. | 1999-11-09 |
| K983441 | C3 | Abbott Laboratories | 1998-11-04 |
| K964298 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 |
Legacy Summary#
summary
FDA Review#
Decision Summary