MODIFICATION TO: UNICAP SPECIFIC IGE— 510(k) K051218
Substantially EquivalentPharmacia Diagnostics AB
FDA 510(k) clearance K051218 for MODIFICATION TO: UNICAP SPECIFIC IGE, Substantially Equivalent on 2005-06-09. Applicant: Pharmacia Diagnostics AB. Device class: 2.
Clearance details
- Applicant
- Pharmacia Diagnostics AB
- Product code
- Code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Portage, MI, US
Recent devices under product code DHB
view allMore clearances from Pharmacia Diagnostics AB
view allRecalls naming K051218
K-number listed on FDA's recall record- Z-2397-2019 — Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.
- Z-1312-2018 — ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
- Z-1313-2018 — ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051218.
Data sourced from openFDA. This site is unofficial and independent of the FDA.