The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Ids-isys 17-oh Progesterone Control Set, Ids-isys 17-oh Progesterone Calibration Verifiers.
| Device ID | K161082 |
| 510k Number | K161082 |
| Device Name: | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, GB Ne35 9pd |
| Contact | Mick Henderson |
| Correspondent | Mick Henderson IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, GB Ne35 9pd |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-18 |
| Decision Date | 2016-05-17 |
| Summary: | summary |