The following data is part of a premarket notification filed by Intl. Immunoassay Laboratories, Inc. with the FDA for Labelling Changes To Impres-mb-x.
| Device ID | K903508 |
| 510k Number | K903508 |
| Device Name: | LABELLING CHANGES TO IMPRES-MB-X |
| Classification | U.v. Method, Cpk 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 | JHW |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-31 |
| Decision Date | 1990-09-07 |