510(k) K040434
- Device
- ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K040434
- Product code
- DEW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-03-10
- Date received
- 2004-02-19
- Regulation
- 866.5510
- Classification name
- Igg, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHERRI L COENEN
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 2084025
- 3005094123
- 3006198300
- 3003795116
- 3009189893
- 1181121
- 9610099
- 2050012
- 9610806
- 9615037
- 3005333358
- 9610529
- 3002809144
- 9615754
- 1000403749
- 3003423869
- 3013059683
- 3019906
- 3004493545
- 3016438761
- 2050010
- 2242436
- 9610126
- 3003601075
- 3000148879
Source Documents#
Other 510(k) Records For Product Code DEW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050113 | TINA-QUANT IGG GEN.2 | Roche Diagnostics Corp. | 2005-02-08 |
| K010617 | SPIFE IFE CALIBRATOR AND CONTROL KIT | Helena Laboratories | 2001-03-15 |
| K993928 | WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD | Wako Chemicals USA, Inc. | 2000-01-18 |
| K993281 | K-ASSAY IGG | Kamiya Biomedical Co. | 1999-11-09 |
| K983221 | IGG | Abbott Laboratories | 1998-11-04 |
| K965108 | SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT | Beckman Instruments, Inc. | 1997-03-06 |
| K963974 | IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN | Beckman Instruments, Inc. | 1997-03-06 |
| K963868 | IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) | Beckman Instruments, Inc. | 1997-02-10 |
| K962202 | QUANTEX IGG | Instrumentation Laboratory CO | 1996-09-26 |
| K955798 | IGG IMMUNOTURBIDIMETRIC & CALIBRATOR | Randox Laboratories, Ltd. | 1996-04-05 |
| K951635 | BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL | Beckman Instruments, Inc. | 1995-05-15 |
| K943997 | BEHRING NEPHELOMETER II | Behring Diagnostics, Inc. | 1994-10-03 |
| K934324 | OT IGG SORBENT | Organon Teknika Corp. | 1994-04-21 |
| K933314 | RADIAS FERRITIN ENZYME IMMUNOASSAY | Bio-Rad | 1993-09-08 |
| K924197 | ZORBA(TM) IGG REMOVAL REAGENT | Zeus Scientific, Inc. | 1992-12-15 |
Legacy Summary#
summary
FDA Review#
Decision Summary