BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
FDA 510(k) clearance K170509 · decided 2017-05-19
Clearance details
- K-number
- K170509
- Device name
- BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
- Applicant
- Bio-Rad Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2017-02-21
- Decision date
- 2017-05-19
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- PUQ
- Device class
- 2
- Regulation number
- 866.3510
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Benicia, CA, US
- Third-party review
- No
- Expedited review
- No
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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 |