The following data is part of a premarket notification filed by Dexall Biomedical Labs, Inc. with the FDA for Allerg*ens Enzyme Immunoassay Kit.
Device ID | K864696 |
510k Number | K864696 |
Device Name: | ALLERG*ENS ENZYME IMMUNOASSAY 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 | 1986-12-01 |
Decision Date | 1987-03-17 |