BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT— 510(k) K120959
Substantially EquivalentBio-Rad Laboratories
FDA 510(k) clearance K120959 for BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT, Substantially Equivalent on 2012-06-22. Applicant: Bio-Rad Laboratories. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories
- Product code
- Code MXJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Benicia, CA, US
Recent devices under product code MXJ
view allMore clearances from Bio-Rad Laboratories
view all- K183446 — BioPlex 2200 Lyme Total
- K180577 — BioPlex 2200 25-OH Vitamin D Kit
- K170509 — BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
- K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
- K163015 — Liquichek Tumor Marker Control-Level 1 +3 more
Adverse events under product code MXJ
product code MXJ- Injury
- 139
- Total
- 139
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.