The following data is part of a premarket notification filed by Dexall Biomedical Labs, Inc. with the FDA for Additional Allergens For Allerg*ens Eia Kit.
| Device ID | K875066 |
| 510k Number | K875066 |
| Device Name: | ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | DEXALL BIOMEDICAL LABS, INC. 145-4 PROFESSIONAL DR. Gaithersburg, MD 20879 |
| Contact | Hubscher, Phd |
| Correspondent | Hubscher, Phd DEXALL BIOMEDICAL LABS, INC. 145-4 PROFESSIONAL DR. Gaithersburg, MD 20879 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-09 |
| Decision Date | 1988-01-29 |