The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for 25-hydroxy Vitamin Ds Eia.
| Device ID | K142351 |
| 510k Number | K142351 |
| Device Name: | 25-Hydroxy Vitamin Ds EIA |
| Classification | System, Test, Vitamin D |
| Applicant | IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear, GB Ne35 9pd |
| Contact | Mick Henderson |
| Correspondent | Mick Henderson 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 | 2014-08-22 |
| Decision Date | 2015-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060169690455 | K142351 | 000 |