The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Eskachem, Ck-mb Reagent.
| Device ID | K792023 |
| 510k Number | K792023 |
| Device Name: | ESKACHEM, CK-MB REAGENT |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-09 |
| Decision Date | 1979-10-30 |