AIA-PACK IGE II ASSAY— 510(k) K972697
Substantially EquivalentTosoh Medics, Inc.
FDA 510(k) clearance K972697 for AIA-PACK IGE II ASSAY, Substantially Equivalent on 1997-10-03. Applicant: Tosoh Medics, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Medics, Inc.
- 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
- Foster City, CA, US
Recent devices under product code DGC
view all- K231151 — Kenota 1 Total IgE; Kenota 1 (instrument)
- K214068 — Quantia IgE
- K220178 — Total Immunoglobulin E (IgE)
- 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
More clearances from Tosoh Medics, Inc.
view allRecalls naming K972697
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972697.
Data sourced from openFDA. This site is unofficial and independent of the FDA.