ACCESS RUBELLA IGG
FDA 510(k) clearance K954687 · decided 1996-04-09
Clearance details
- K-number
- K954687
- Device name
- ACCESS RUBELLA IGG
- Applicant
- Bio-Rad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-10-11
- Decision date
- 1996-04-09
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- LFX
- Device class
- 2
- Regulation number
- 866.3510
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Access Rubella IgG (K250588) | Beckman Coulter, Inc. | 2025-11-17 |
| Alinity i Rubella IgG (K243168) | Abbott Laboratories | 2025-06-20 |
| LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM (K122397) | DiaSorin, Inc. | 2012-09-06 |
| MAGO 4S (K093101) | Diamedix Corp. | 2011-01-21 |
| BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM (K092587) | Bio-Rad Laboratories | 2010-12-03 |
| ELECSYS RUBELLA IGM IMMUNOASSAY (K092322) | Roche Diagnostics | 2010-03-12 |
| VIDAS RUB IGG (K080766) | bioMerieux, Inc. | 2008-12-23 |
| ELECSYS RUBELLA IGG IMMUNOASSAY (K072617) | Roche Diagnostics Corp. | 2008-12-05 |
| DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS (K073390) | DiaSorin, Inc. | 2008-11-21 |
| ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM (K063186) | Zeus Scientific, Inc. | 2007-03-21 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS (K063143) | Ortho-Clinical Diagnostics, Inc. | 2006-12-26 |
| ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY (K031606) | Beckman Coulter, Inc. | 2003-06-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MONOLISA ANTI-HBC IGM EIA (P060034/S008) | Bio-Rad Laboratories, Inc. | 2014-03-19 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S007) | Bio-Rad Laboratories, Inc. | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S007) | Bio-Rad Laboratories, Inc. | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S005) | Bio-Rad Laboratories, Inc. | 2011-04-28 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S003) | Bio-Rad Laboratories, Inc. | 2010-12-30 |
| MONOLISA ANTI-HBC IGM EIA (P060034/S005) | Bio-Rad Laboratories, Inc. | 2010-11-23 |