LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207— 510(k) K984476
Substantially EquivalentBio-Rad
FDA 510(k) clearance K984476 for LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207, Substantially Equivalent on 1998-12-22. Applicant: Bio-Rad. Device class: 2.
Clearance details
- Applicant
- Bio-Rad
- Product code
- Code LKO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code LKO
view all- K191085 — Maverick RNP Assay and Maverick Diagnostic System
- K140224 — EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)
- K123261 — EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
- K083117 — ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
- K071210 — MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
More clearances from Bio-Rad
view allData sourced from openFDA. This site is unofficial and independent of the FDA.