EMBRIA-CK
Fluorometric Method, Cpk Or Isoenzymes
INTL. IMMUNOASSAY LABORATORIES, INC.
The following data is part of a premarket notification filed by Intl. Immunoassay Laboratories, Inc. with the FDA for Embria-ck.
Pre-market Notification Details
| Device ID | K801728 |
| 510k Number | K801728 |
| Device Name: | EMBRIA-CK |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | INTL. IMMUNOASSAY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-24 |
| Decision Date | 1980-09-26 |
Trademark Results [EMBRIA-CK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EMBRIA-CK 73299841 1226368 Dead/Cancelled |
International Immunoassay Laboratories,Inc. 1981-03-05 |
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