510(k) K142811
- Device
- IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)
- Applicant
- Siemens Healthcare Diagnostics Inc.
- 510(k) number
- K142811
- Product code
- JJX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-10-29
- Date received
- 2014-09-29
- 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
- Asha Gartland
- Address
- 511 Benedict Ave. Tarrytown NY US 10591 10591
FDA Registration Numbers#
- 3003539867
- 3016438761
- 2432495
- 9681753
- 3001452053
- 3002895169
- 3011420269
- 9610240
- 3032705
- 9610566
- 8020316
- 2245451
- 9610529
- 3003132490
- 2084025
- 3010152370
- 3007363438
- 9681518
- 3010939897
- 3013660430
- 3002800697
- 3037000637
- 3004637226
- 3005621222
- 3003871639
- 3017520431
- 2531491
- 3007652384
- 3013472743
- 3006371704
- 9710337
- 3012113276
- 3013982035
- 3026478115
- 9613069
- 3009491259
- 9610806
- 3008156187
- 3003600763
- 1000115322
- 3018940143
- 9610099
- 2030633
- 1450743
- 3026478116
- 3003559191
- 3002792284
- 1649661
- 3004529019
- 1000403749
- 2032098
- 3033507883
- 3005393828
- 2521625
- 1832216
- 2122870
- 3006948883
- 1119779
- 3011979858
- 8043909
- 3009092698
- 1643621
- 2182595
- 3010864358
- 3013223546
- 3006644620
- 3011121740
- 3017772438
- 3020885868
- 1645225
- 3003902721
- 2245578
- 3012422258
- 3005625991
- 1319681
- 3015347724
- 9615777
- 3004434309
- 9616936
- 3013160357
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 |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers | Immunodiagnostic Systems , Ltd. | 2016-05-17 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary