The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Clinical Assays Gammacoat [125] Estradiol Radioimmunoassay Kit.
| Device ID | K941168 |
| 510k Number | K941168 |
| Device Name: | CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 |
| Contact | Mary E Best |
| Correspondent | Mary E Best INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 |
| Product Code | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-14 |
| Decision Date | 1994-09-07 |