BARTELS RUBELLA IGG EIA
FDA 510(k) clearance K922586 · decided 1992-09-17
Clearance details
- K-number
- K922586
- Device name
- BARTELS RUBELLA IGG EIA
- Applicant
- Baxter Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-27
- Decision date
- 1992-09-17
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- LFX
- Device class
- 2
- Regulation number
- 866.3510
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Bellevue, WA, US
- Third-party review
- No
- Expedited review
- No
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| 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.