The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Acth Standard Matrix.
| Device ID | K842099 |
| 510k Number | K842099 |
| Device Name: | ACTH STANDARD MATRIX |
| Classification | Calibrator, Secondary |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-25 |
| Decision Date | 1984-08-17 |