LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK— 510(k) K123798
Substantially EquivalentBio-Rad Laboratories
FDA 510(k) clearance K123798 for LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK, Substantially Equivalent on 2013-01-09. Applicant: Bio-Rad Laboratories. Device class: 1.
Clearance details
- Applicant
- Bio-Rad Laboratories
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code JJX
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 JJX
product code JJX- Other
- 2
- Total
- 2
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.