The following data is part of a premarket notification filed by Immunodiagnostic Systems, Inc. with the FDA for Ids-isys 25-hydroxy Vitamin D Assay, Ids-isys 25-hydroxy Vitamin D Control Set.
| Device ID | K091849 |
| 510k Number | K091849 |
| Device Name: | IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET |
| Classification | System, Test, Vitamin D |
| Applicant | IMMUNODIAGNOSTIC SYSTEMS, INC. 17029 EAST ENTERPRISE DR. SUITE 1 Fountain Hills, AZ 85268 |
| Contact | Ken Gibbs |
| Correspondent | Ken Gibbs IMMUNODIAGNOSTIC SYSTEMS, INC. 17029 EAST ENTERPRISE DR. SUITE 1 Fountain Hills, AZ 85268 |
| Product Code | MRG |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-22 |
| Decision Date | 2010-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060169693968 | K091849 | 000 |
| 05060169691223 | K091849 | 000 |