The following data is part of a premarket notification filed by Intl. Immunoassay Laboratories, Inc. with the FDA for Cardi-ck Eia Test Kit Ck-mb Isoenzyme.
| Device ID | K843007 |
| 510k Number | K843007 |
| Device Name: | CARDI-CK EIA TEST KIT CK-MB ISOENZYME |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | INTL. IMMUNOASSAY LABORATORIES, 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 | 1984-07-31 |
| Decision Date | 1984-09-07 |