The following data is part of a premarket notification filed by Intl. Immunoassay Laboratories, Inc. with the FDA for Impres-mb Reagent A And Reagent B.
| Device ID | K890543 |
| 510k Number | K890543 |
| Device Name: | IMPRES-MB REAGENT A AND REAGENT B |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | INTL. IMMUNOASSAY LABORATORIES, INC. 1900 WYATT DR., #11 Santa Clara, CA 95054 |
| Contact | Shah, Phd |
| Correspondent | Shah, Phd INTL. IMMUNOASSAY LABORATORIES, INC. 1900 WYATT DR., #11 Santa Clara, CA 95054 |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-03 |
| Decision Date | 1989-03-13 |