510(k) K052982
- Device
- ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
- Applicant
- Roche Diagnostics
- 510(k) number
- K052982
- Product code
- JIT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-10-28
- Date received
- 2005-10-24
- Regulation
- 862.1150
- Classification name
- Calibrator, Secondary
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RANDY JOHNSON
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 2029372
- 3002637618
- 3009711478
- 2050012
- 3000148879
- 1063851
- 2155
- 9681576
- 1616487
- 2432235
- 1221361
- 3006198300
- 3008344661
- 1181055
- 3003539867
- 3005529799
- 3005847079
- 3005333358
- 3003561301
- 1036362
- 1000403749
- 8023018
- 8020316
- 9610806
- 3013059683
- 3016438761
- 2521625
- 3004875840
- 3009518015
- 1832816
- 8020888
- 2050010
- 3007118747
- 2245451
- 3027977508
- 9614373
- 3013660430
- 1415939
- 3002806944
- 3009189893
- 2030861
- 2431530
- 3029973107
- 9610529
- 3003030793
- 3004192065
- 3010421384
- 3014643041
- 1319436
- 3002642396
- 3014607865
- 3003985394
- 3005625991
- 3012240236
- 3012963943
- 2435505
- 8032314
- 8043889
- 2032900
- 3012289015
- 1221645
- 9613959
- 3004493545
- 3000308930
- 9680746
- 3010939897
- 3007111389
- 1827821
- 8021924
- 1220972
- 2915274
- 2025099
- 3002809144
- 3003422726
- 3003460426
- 9681753
- 9710337
- 1319809
- 2085064
- 3014279513
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 |
| K163534 | Lumipulse G FSH-N Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| K163546 | Lumipulse G Progesterone-N Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| K163521 | Lumipulse G LH Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| K163544 | Lumipulse G Prolactin | 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