The following data is part of a premarket notification filed by Seragen Diagnostics, Inc. with the FDA for Ck/ld Isoenzymes Controls(human).
| Device ID | K851520 |
| 510k Number | K851520 |
| Device Name: | CK/LD ISOENZYMES CONTROLS(HUMAN) |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | SERAGEN DIAGNOSTICS, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | Michael J Sullivan |
| Correspondent | Michael J Sullivan SERAGEN DIAGNOSTICS, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-06-25 |