The following data is part of a premarket notification filed by Phadia Ab with the FDA for 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 Cu.
| Device ID | K161899 |
| 510k Number | K161899 |
| Device Name: | 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 Cu |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | PHADIA AB RAPSGATAN 7P Uppsala, SE 75137 |
| Contact | Ulf Karlberg |
| Correspondent | Martin Mann PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-11 |
| Decision Date | 2016-07-28 |
| Summary: | summary |