BIOPLEX VASCULITIS KIT
FDA 510(k) clearance K072358 · decided 2007-10-31
Clearance details
- K-number
- K072358
- Device name
- BIOPLEX VASCULITIS KIT
- Applicant
- Bio-Rad Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2007-08-22
- Decision date
- 2007-10-31
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- MVJ
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bio-Rad Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ATHENA MULTI-LYTE GBM TEST SYSTEM (K071219) | Zeus Scientific, Inc. | 2007-12-06 |
| PHASE II GBM IGG ANTIBODY EIA TEST (K011348) | Scimedx Corp. | 2001-06-25 |
| AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA (K991890) | Cogent Diagnotics , Ltd. | 1999-08-09 |
| BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT (K984619) | The Binding Site, Ltd. | 1999-02-23 |
| QUANTA LITE GBM ELISA (K984336) | Inova Diagnostics, Inc. | 1999-02-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MONOLISA ANTI-HBS EIA (P050048/S010) | Bio-Rad Laboratories | 2025-04-18 |
| BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S009) | Bio-Rad Laboratories | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S008) | Bio-Rad Laboratories | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT (P050048/S007) | Bio-Rad Laboratories | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S004) | Bio-Rad Laboratories | 2011-04-25 |
| MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT (P050048/S005) | Bio-Rad Laboratories | 2010-11-23 |
| BIO-RAD MONOLISA ANTI -HBS EIA (P050048/S006) | Bio-Rad Laboratories | 2010-09-27 |
| BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S002) | Bio-Rad Laboratories | 2010-03-12 |