The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Gamma-b 25-hydroxy Vitamin D Ria.
| Device ID | K991998 |
| 510k Number | K991998 |
| Device Name: | GAMMA-B 25-HYDROXY VITAMIN D RIA |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-14 |
| Decision Date | 1999-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060169690004 | K991998 | 000 |