Ferritin Calibrator Set, Catalog No. 8203
FDA 510(k) K053291 · Reference Diagnostics, Inc.
510(k) numberK053291
Submission
- Device name
- Ferritin Calibrator Set, Catalog No. 8203
- Applicant
- Reference Diagnostics, Inc.
Bedford, MA, US - Received
- November 25, 2005
- Decision date
- March 13, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement 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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|---|---|---|---|
| K171168 | VITROS Immunodiagnostic Products Insulin CalibratorsJIT · Abbreviated | Ortho Clinical Diagnostics | 05/16/2017SE |
| K170938 | CalSet IGF-1JIT · Traditional | Roche Diagnostics | 04/26/2017SE |
| K170160 | Abbott ARCHITECT Free T3JIT · Traditional | Abbott Laboratories | 02/15/2017SE |
| K163546 | Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163534 | Lumipulse G FSH-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| 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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| 510(k) | Device | Decision |
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| K053211 | Rdi Hsferritin KitDBF · Traditional | 03/13/2006SE |
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| K030044 | Extended Range HS CRP Kit, Cat NO:9200DCK · Traditional | 09/30/2003SE |
| K030772 | Rdi Extended Range CRP Calibrator SetJIT · Abbreviated | 04/11/2003SE |
| K021609 | Rdi HS CRP KitDCK · Traditional | 06/27/2002SE |
| K021607 | Rdi HS CRP Calibrator SetJIT · Abbreviated | 06/27/2002SE |
| K000783 | Direct Tibc CalibratorJIT · Abbreviated | 05/04/2000SE |
| K000781 | Direct Tibc KitJMO · Traditional | 05/02/2000SE |
| K990216 | Magnetic Tibc KitJMO · Traditional | 02/16/1999SE |
| K984107 | Rdi Direct LDL Cholesterol TestMRR · Traditional | 01/28/1999SE |
Questions and answers
When was Ferritin Calibrator Set, Catalog No. 8203 cleared by the FDA?
Ferritin Calibrator Set, Catalog No. 8203 (K053291) received a 510(k) decision of Substantially Equivalent on March 13, 2006, 108 days after the submission was received.
What is the product code of K053291?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.