The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Gamma-b 1,25-dihydroxy Vitamin D.
| Device ID | K042519 |
| 510k Number | K042519 |
| Device Name: | GAMMA-B 1,25-DIHYDROXY VITAMIN D |
| Classification | System, Test, Vitamin D |
| Applicant | IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear, GB Ne35 9pd |
| Contact | Paul Puntin |
| Correspondent | Paul Puntin IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear, GB Ne35 9pd |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-16 |
| Decision Date | 2004-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060169690028 | K042519 | 000 |
| 05060169690011 | K042519 | 000 |