510(k) K143352
- Device
- IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material
- Applicant
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- 510(k) number
- K143352
- Product code
- JJX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-12-24
- Date received
- 2014-11-24
- Regulation
- 862.1660
- Classification name
- Single (specified) Analyte Controls (assayed And Unassayed)
- Medical specialty
- Clinical Chemistry
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sara Kastrup
- Address
- 511 Benedict Ave. Tarrytown NY US 10591 10591
FDA Registration Numbers#
- 9610102
- 3017500903
- 1827821
- 3001058982
- 3003951180
- 3014353045
- 2435505
- 1720929
- 2030633
- 3008344661
- 3042026207
- 1645225
- 2032364
- 3002809144
- 3011213605
- 8023024
- 2432235
- 3005395953
- 1717966
- 3005450604
- 8021924
- 3007652384
- 9610126
- 8023018
- 3017520431
- 3011325031
- 3006948883
- 3013223546
- 3020885868
- 2026994
- 2432495
- 3006532271
- 9681753
- 3000308930
- 9710595
- 3003674698
- 3004145393
- 3010127294
- 3003917514
- 3015347724
- 2032682
- 1000403749
- 1000115322
- 3012113276
- 3009491259
- 9616673
- 3011121740
- 3033507883
- 3005621222
- 3006198300
- 3007088335
- 3005798905
- 3002637618
- 9610240
- 3004193489
- 3005643513
- 3006644620
- 3006371704
- 3003460426
- 3033967997
- 1810909
- 3006755541
- 2032087
- 2123774
- 9681518
- 3001452053
- 3007118747
- 1319808
- 2032098
- 3012104670
- 3010939897
- 9615837
- 3014680791
- 3017772438
- 3014150341
- 3008156187
- 1218959
- 3010864358
- 3030978471
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