The following data is part of a premarket notification filed by Intl. Immunoassay Laboratories, Inc. with the FDA for Imack-mb Test Procedure (modification).
| Device ID | K874545 |
| 510k Number | K874545 |
| Device Name: | IMACK-MB TEST PROCEDURE (MODIFICATION) |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | INTL. IMMUNOASSAY LABORATORIES, INC. 1900 WYATT DR., #11 Santa Clara, CA 95054 |
| Contact | Shah, Ph.d. |
| Correspondent | Shah, Ph.d. INTL. IMMUNOASSAY LABORATORIES, INC. 1900 WYATT DR., #11 Santa Clara, CA 95054 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-03 |
| Decision Date | 1987-12-18 |