The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Biotis Abnormal Clinical Chem Serum-.
Device ID | K840458 |
510k Number | K840458 |
Device Name: | BIOTIS ABNORMAL CLINICAL CHEM SERUM- |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | OTISVILLE BIOTECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-02 |
Decision Date | 1984-04-17 |