The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Pth-mm Ii 125i Radioimmunoassay (ria).
| Device ID | K901711 |
| 510k Number | K901711 |
| Device Name: | PTH-MM II 125I RADIOIMMUNOASSAY (RIA) |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| 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 | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-13 |
| Decision Date | 1990-07-16 |