The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Seralyzer Drug Assay Control Serum.
| Device ID | K833977 |
| 510k Number | K833977 |
| Device Name: | SERALYZER DRUG ASSAY CONTROL SERUM |
| Classification | Calibrators, Drug Specific |
| Applicant | MILES LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-17 |
| Decision Date | 1984-03-19 |