The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Incstar 25-hydroxyvitmin D 1251 Ria.
| Device ID | K953567 |
| 510k Number | K953567 |
| Device Name: | INCSTAR 25-HYDROXYVITMIN D 1251 RIA |
| Classification | System, Test, Vitamin D |
| Applicant | INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Contact | Mary Ellen Best |
| Correspondent | Mary Ellen Best INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-31 |
| Decision Date | 1996-09-25 |
| Summary: | summary |