IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH— 510(k) K133404
Substantially EquivalentPhadia AB
FDA 510(k) clearance K133404 for IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH, Substantially Equivalent on 2014-02-24. Applicant: Phadia AB. Device class: 2.
Clearance details
- Applicant
- Phadia AB
- 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
- Special
- Location
- Portage, MI, US
Recent devices under product code DGC
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- 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
More clearances from Phadia AB
view all- K253367 — EliA CTD 13 Screen
- K212181 — ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
- K210902 — EliA Ro52, EliA Ro60
- K202540 — EliA Rib-P
- K202541 — EliA RNA Pol III
Recalls naming K133404
K-number listed on FDA's recall record- Z-0387-2018 — Phadia 1000 Instrument, Article Number 12-3800-01.
- Z-0947-2015 — Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133404.
Data sourced from openFDA. This site is unofficial and independent of the FDA.