BioPlex 2200 Lyme Total— 510(k) K183446
Substantially EquivalentBio-Rad Laboratories
FDA 510(k) clearance K183446 for BioPlex 2200 Lyme Total, Substantially Equivalent on 2019-03-12. Applicant: Bio-Rad Laboratories. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories
- Product code
- Code LSR
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Benicia, CA, US
Recent devices under product code LSR
view allMore clearances from Bio-Rad Laboratories
view all- 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
- K152679 — Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
Data sourced from openFDA. This site is unofficial and independent of the FDA.