The following data is part of a premarket notification filed by Dexall Biomedical Labs, Inc. with the FDA for Allerg-e Ige Enzyme Immunoassay Kit.
| Device ID | K853607 |
| 510k Number | K853607 |
| Device Name: | ALLERG-E IGE ENZYME IMMUNOASSAY KIT |
| Classification | Ige, Peroxidase, Antigen, Antiserum, Control |
| Applicant | DEXALL BIOMEDICAL LABS, INC. 145-4 PROFESSIONAL DR. Gaithersburg, MD 20879 |
| Contact | Thomas Hubscher |
| Correspondent | Thomas Hubscher DEXALL BIOMEDICAL LABS, INC. 145-4 PROFESSIONAL DR. Gaithersburg, MD 20879 |
| Product Code | DGO |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-28 |
| Decision Date | 1985-11-07 |