The following data is part of a premarket notification filed by Intl. Immunoassay Laboratories, Inc. with the FDA for Modified Label For Embria-ck, Quick-mb/micromi-mb.
| Device ID | K901450 |
| 510k Number | K901450 |
| Device Name: | MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB |
| Classification | Chromatographic Separation, 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 | JHT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-28 |
| Decision Date | 1990-05-15 |