The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Ck-mb (dsl #3200).
| Device ID | K904721 |
| 510k Number | K904721 |
| Device Name: | DSL CK-MB (DSL #3200) |
| Classification | Chromatographic Separation, Cpk Isoenzymes |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | R Willis |
| Correspondent | R Willis DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | JHT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-18 |
| Decision Date | 1990-12-13 |