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 |