510(k) K161082
- Device
- IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers
- Applicant
- IMMUNODIAGNOSTIC SYSTEMS LTD.
- 510(k) number
- K161082
- Product code
- JJX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-05-17
- Date received
- 2016-04-18
- Regulation
- 862.1660
- Classification name
- Single (specified) Analyte Controls (assayed And Unassayed)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICK HENDERSON
- Address
- 10 Didcot Way Bolden Business Park Boldon GB NE35 9PD NE35 9PD
FDA Registration Numbers#
- 3003600763
- 2026994
- 9681518
- 3003985394
- 3011121740
- 3002642396
- 2250051
- 3015347724
- 1000403749
- 2030633
- 9610566
- 9612316
- 3000148879
- 3004529019
- 3010830834
- 1318354
- 3006198300
- 3004130086
- 9614373
- 3003674698
- 3003902721
- 3004973408
- 8023018
- 8020888
- 3007134734
- 3009518015
- 3002809144
- 9616673
- 9615837
- 3007363438
- 3013223546
- 3017500903
- 1122376
- 9681576
- 3005094123
- 2531491
- 3016698405
- 3011979858
- 9610099
- 3003593973
- 1000115322
- 1319808
- 3002895169
- 1722684
- 3005333358
- 3004193489
- 3007111389
- 9611444
- 2434178
- 1616487
- 3024512705
- 3004009431
- 3018940143
- 3012471076
- 2032364
- 3030171742
- 3011325031
- 8023024
- 3003749380
- 3003917514
- 3017550662
- 3016438761
- 2020715
- 1219029
- 3004434309
- 3011989923
- 3030978471
- 3006532271
- 3004176168
- 9610240
- 1450743
- 3010131137
- 3045951983
- 2085064
- 3037000637
- 3032705
- 2024800
- 2016706
- 1220649
- 2432235
Source Documents#
Other 510(k) Records For Product Code JJX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170678 | Beta-CrossLaps CalCheck 5 | Roche Diagnostics | 2017-04-04 |
| K162173 | Elecsys CYFRA 21-1 CalCheck 5 | Roche Diagnostics | 2017-01-12 |
| K162514 | Multichem A1c | Technopath Manufacturing | 2016-10-26 |
| K161874 | Audit MicroControls Linearity DROP LQ Blood Glucose | Aalto Scientific, Ltd. | 2016-08-10 |
| K161522 | LIAISON EBV IgM Serum Control Set | DiaSorin, Inc. | 2016-06-30 |
| K161526 | LIAISON CMV IgM Serum Control Set | DiaSorin, Inc. | 2016-06-30 |
| K152117 | Dropper hsCRP High Sensitivity CRP Control | Quantimetrix Corporation | 2016-04-21 |
| K151742 | Contour Next Control Solution | Bayer Healthcare | 2015-09-23 |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material | Siemens Healthcare Diagnostics, Inc. | 2015-07-17 |
| K150955 | Elecsys Progesterone III Cal Check 5 | Roche Diagnostics | 2015-05-01 |
| K150132 | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module | Siemens Healthcare Diagnostics | 2015-04-13 |
| K143324 | IDS-iSYS CTX-I Calibration Verifiers | Immunodiagnostic Systems , Ltd. | 2015-03-30 |
| K143373 | IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2015-02-26 |
| K143636 | IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2015-02-25 |
| K143680 | ADVIA Centaur IgE Master Curve Material | Siemens Healthcare Diagnostics, Inc. | 2015-01-27 |
Legacy Summary#
summary
FDA Review#
Decision Summary