The following data is part of a premarket notification filed by Clinical Reference Laboratory, Inc. with the FDA for Image-ige.
| Device ID | K853025 |
| 510k Number | K853025 |
| Device Name: | IMAGE-IGE |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | CLINICAL REFERENCE LABORATORY, INC. 11844 W. 85TH ST. Lenexa, KA 66214 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-18 |
| Decision Date | 1985-08-22 |