The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl 1700.
| Device ID | K822897 |
| 510k Number | K822897 |
| Device Name: | DSL 1700 |
| Classification | U.v. Method, Cpk Isoenzymes |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JHW |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-28 |
| Decision Date | 1982-12-15 |