LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK— 510(k) K123663
Substantially EquivalentBio-Rad Laboratories
FDA 510(k) clearance K123663 for LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK, Substantially Equivalent on 2012-12-27. Applicant: Bio-Rad Laboratories. Device class: 1.
Clearance details
- Applicant
- Bio-Rad Laboratories
- Product code
- Code JJY
- 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 JJY
view all- K162530 — Multichem IA Plus
- K163629 — Audit MicroControls Linearity FD Tumor Markers II
- K163015 — Liquichek Tumor Marker Control-Level 1 +3 more
- K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
- K150300 — Liquichek Cardiac Markers Plus Control LT
More 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
- 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.