The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Epo-trac By Radioimmunoassay (ria).
Device ID | K893393 |
510k Number | K893393 |
Device Name: | EPO-TRAC BY RADIOIMMUNOASSAY (RIA) |
Classification | Assay, Erythropoietin |
Applicant | INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
Contact | G Tallas |
Correspondent | G Tallas INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
Product Code | GGT |
CFR Regulation Number | 864.7250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-01 |
Decision Date | 1989-11-21 |