The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Epo-trac(tm) 125i Radioimmunoassay (ria).
Device ID | K902639 |
510k Number | K902639 |
Device Name: | EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) |
Classification | Assay, Erythropoietin |
Applicant | INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
Contact | David H Short |
Correspondent | David H Short 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 | 1990-06-14 |
Decision Date | 1990-08-22 |