Roche Diagnostics Cobas Elecsys Prolactin II Calset
FDA 510(k) K052982 · Roche Diagnostics
510(k) numberK052982
Submission
- Device name
- Roche Diagnostics Cobas Elecsys Prolactin II Calset
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- October 24, 2005
- Decision date
- October 28, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K170938 | CalSet IGF-1JIT · Traditional | Roche Diagnostics | 04/26/2017SE |
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| K163544 | Lumipulse G ProlactinJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163521 | Lumipulse G LH CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163078 | Dc-Uibc-CalJIT · Abbreviated | Sekisui Diagnostics P.E.I., Inc. | 12/08/2016SE |
| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 12/01/2016SE |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorJIT · Special | Siemens Healthcare Diagnostics | 11/17/2016SE |
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Questions and answers
When was Roche Diagnostics Cobas Elecsys Prolactin II Calset cleared by the FDA?
Roche Diagnostics Cobas Elecsys Prolactin II Calset (K052982) received a 510(k) decision of Substantially Equivalent on October 28, 2005, 4 days after the submission was received.
What is the product code of K052982?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.