510(k) K100293
- Device
- ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810
- Applicant
- SIEMENS HEATLHCARE DIAGNOSTICS INC
- 510(k) number
- K100293
- Product code
- JIT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-03-19
- Date received
- 2010-02-02
- Regulation
- 862.1150
- Classification name
- Calibrator, Secondary
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ernest Joseph
- Address
- 511 Benedict Ave. Tarrytown NY US 10591 10591
FDA Registration Numbers#
- 3013660430
- 9611444
- 1063851
- 3003030793
- 9610806
- 9680746
- 2432235
- 9610529
- 3008344661
- 9612316
- 3009518015
- 2521625
- 3007662974
- 2026994
- 1221361
- 2155
- 9610746
- 3016438761
- 1832816
- 3027977508
- 3012471076
- 3003422726
- 3003871639
- 2085064
- 8020888
- 2029372
- 1319681
- 1219029
- 3000308930
- 3002806944
- 3000148879
- 9614373
- 2084025
- 3004192065
- 3012240236
- 3005094123
- 2431530
- 3011926203
- 3009189893
- 3004434070
- 9610099
- 3003559191
- 3014353045
- 3005333358
- 1319809
- 9613959
- 3010421384
- 3010939897
- 3002809144
- 1000403749
- 3005622096
- 8032314
- 2032087
- 3002895169
- 9610987
- 3004493545
- 3029973107
- 9681753
- 3007111389
- 2435505
- 8021924
- 1218959
- 3003593973
- 9681576
- 3032705
- 8020316
- 2050012
- 8043909
- 2250051
- 2182595
- 3007118747
- 1036362
- 2517506
- 8031673
- 3011989923
- 1643621
- 3013059683
- 3002637618
- 3012348571
- 1415939
Source Documents#
Other 510(k) Records For Product Code JIT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | Ortho Clinical Diagnostics | 2017-05-16 |
| K170938 | CalSet IGF-1 | Roche Diagnostics | 2017-04-26 |
| K170160 | Abbott ARCHITECT Free T3 | Abbott Laboratories | 2017-02-15 |
| K163546 | Lumipulse G Progesterone-N Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| K163534 | Lumipulse G FSH-N Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| K163544 | Lumipulse G Prolactin | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| K163521 | Lumipulse G LH Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| K163078 | DC-UIBC-CAL | Sekisui Diagnostics P.E.I., Inc. | 2016-12-08 |
| K163053 | Lumipulse G E2-III Calibrators | Fujirebio Diagnostics,Inc. | 2016-12-01 |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator | Siemens Healthcare Diagnostics | 2016-11-17 |
| K160113 | ST AIA-PACK hsE2 Calibrator Set | Tosoh Bioscience, Inc. | 2016-02-17 |
| K153417 | ST AIA-PACK PROG III Calibrator Set | Tosoh Bioscience, Inc. | 2015-12-18 |
| K152526 | Elecsys Progesterone III CalSet | Roche Diagnostics | 2015-10-02 |
| K151566 | Abbott ARCHITECT Total T4 Calibrators | Abbott Laboratories | 2015-07-10 |
| K142985 | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator | Beckman Coulter, Inc. | 2015-02-26 |
Legacy Summary#
summary
FDA Review#
Decision Summary