ISOMUNE-CK
U.v. Method, Cpk Isoenzymes
HOFFMANN-LA ROCHE, INC.
The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Isomune-ck.
Pre-market Notification Details
| Device ID | K810905 |
| 510k Number | K810905 |
| Device Name: | ISOMUNE-CK |
| Classification | U.v. Method, Cpk Isoenzymes |
| Applicant | HOFFMANN-LA ROCHE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHW |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-03 |
| Decision Date | 1981-04-14 |
Trademark Results [ISOMUNE-CK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISOMUNE-CK 73303798 1215426 Dead/Cancelled |
Hoffmann-La Roche Inc. 1981-04-01 |
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