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 |