The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Ids-isys Ctx-1 (crosslaps) Calibration Verifiers, Ids-isys 25 Hydroxy Vitamin D Calibration Verifiers, And Ids-isys....
| Device ID | K111650 |
| 510k Number | K111650 |
| Device Name: | IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear, GB Ne35 9pd |
| Contact | Mick Fenton |
| Correspondent | Mick Fenton IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear, GB Ne35 9pd |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-13 |
| Decision Date | 2011-09-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239021243 | K111650 | 000 |
| 04048474021240 | K111650 | 000 |