The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Normal Clinical Chem. Control Serum-.
| Device ID | K840457 |
| 510k Number | K840457 |
| Device Name: | NORMAL CLINICAL CHEM. CONTROL 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 | 1984-04-13 |