The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Tipsep Digoxin Ria.
Device ID | K852291 |
510k Number | K852291 |
Device Name: | TIPSEP DIGOXIN RIA |
Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep. |
Applicant | NUCLEAR DIAGNOSTICS, INC. 575 ROBBINS DR. Troy, MI 48083 |
Contact | Smart, Ph.d |
Correspondent | Smart, Ph.d NUCLEAR DIAGNOSTICS, INC. 575 ROBBINS DR. Troy, MI 48083 |
Product Code | DNL |
CFR Regulation Number | 862.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-29 |
Decision Date | 1985-06-25 |