The following data is part of a premarket notification filed by Incstar Corp. with the FDA for N-tact(r) Pth Sp Kit.
| Device ID | K921629 |
| 510k Number | K921629 |
| Device Name: | N-TACT(R) PTH SP KIT |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Contact | Meredith G Tallas |
| Correspondent | Meredith G Tallas 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 | 1992-04-06 |
| Decision Date | 1992-05-14 |