The following data is part of a premarket notification filed by Seragen Diagnostics, Inc. with the FDA for Ld-1(immuno) Separation Set.
| Device ID | K851521 |
| 510k Number | K851521 |
| Device Name: | LD-1(IMMUNO) SEPARATION SET |
| Classification | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes |
| 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 | CEX |
| CFR Regulation Number | 862.1445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-05-10 |