510(k) K140505
- Device
- ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL
- Applicant
- Siemens Healthcare Diagnostics Inc.
- 510(k) number
- K140505
- Product code
- JJX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-03-31
- Date received
- 2014-02-27
- 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
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- FATIMA PACHECO
- Address
- 511 Benedict Ave. Tarrytown NY US 10591 10591
FDA Registration Numbers#
- 1122376
- 3003741796
- 3033507883
- 3009129531
- 1063851
- 3003871639
- 3003419906
- 3008789114
- 8043889
- 3005529799
- 3004146366
- 1318354
- 2032682
- 3032705
- 3005094123
- 3026478116
- 1000134386
- 3013160357
- 3016698405
- 3014150341
- 1832816
- 3005450604
- 3005798905
- 8043909
- 3009171251
- 9616673
- 3003522182
- 3013472743
- 3002807722
- 2245451
- 2020715
- 1645225
- 2250051
- 9610126
- 2026994
- 1319681
- 1000403749
- 3002694097
- 2123774
- 3013059683
- 3006371704
- 8031673
- 2032364
- 1717966
- 8020888
- 3009469260
- 3017550662
- 9681753
- 3010152370
- 1000115322
- 9613069
- 3005862821
- 2050010
- 2434178
- 1181121
- 8032314
- 3004529019
- 3011213605
- 3010534606
- 3004176168
- 3002895169
- 3003985394
- 9710492
- 2032900
- 3012422258
- 2432495
- 8020316
- 3010864358
- 2245285
- 3037000637
- 2030633
- 2084025
- 8023024
- 3011420269
- 2050012
- 3004637226
- 2016706
- 2032087
- 3007363438
- 1219029
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