510(k) K040431
- Device
- ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K040431
- Product code
- DAO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-03-10
- Date received
- 2004-02-19
- Regulation
- 866.5550
- Classification name
- Igm (mu Chain Specific), 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#
- 9610099
- 9610529
- 3003423869
- 3013059683
- 3009189893
- 9610126
- 3006198300
- 3003795116
- 3019906
Source Documents#
Other 510(k) Records For Product Code DAO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K982639 | SPIFE URINE IFE | Helena Laboratories | 1998-11-04 |
| K955908 | BOEHRINGER MANNHEIM IGM ASSAY | Boehringer Mannheim Corp. | 1996-02-09 |
| K850586 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M | Applications Lab | 1985-03-14 |
| K841992 | MODIFICATION TO ACS CORONARY GUIDING | Advanced Cardiovascular Systems, Inc. | 1984-06-11 |
| K812487 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM | Dako Corp. | 1981-09-23 |
| K800450 | GEMENI IGM ASSAY | Electro-Nucleonics Laboratories, Inc. | 1980-04-24 |
| K790705 | ANTISERUM TO HUMAN IGM | Kent Laboratories, Inc. | 1979-04-12 |
Legacy Summary#
summary
FDA Review#
Decision Summary