LACRYTEST— 510(k) K034057
Substantially EquivalentAdiatec SA
FDA 510(k) clearance K034057 for LACRYTEST, Substantially Equivalent on 2004-03-09. Applicant: Adiatec SA. Device class: 2.
Clearance details
- Applicant
- Adiatec SA
- Product code
- Code DGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nantes, FR
Recent devices under product code DGC
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- K193493 — ADVIA Centaur Total IgE (tIgE)
- K161899 — ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
Data sourced from openFDA. This site is unofficial and independent of the FDA.