N-Assay Tia Multi CRP Calibrator Set
FDA 510(k) K965110 · Crestat Diagnostics, Inc.
510(k) numberK965110
Submission
- Device name
- N-Assay Tia Multi CRP Calibrator Set
- Applicant
- Crestat Diagnostics, Inc.
Weston, CT, US - Received
- December 20, 1996
- Decision date
- July 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DCK – C-Reactive Protein, Antigen, Antiserum, And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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| K192028 | Yumizen C1200 CRPDCK · Traditional | Horiba Abx SAS | 06/25/2020SE |
| K192118 | CRP VarioDCK · Special | SENTINEL CH. SpA | 11/08/2019SE |
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| K160712 | VITROS Chemistry Products hsCRP ReagentDCK · Traditional | Ortho Clinical Diagnostics | 07/14/2017SE |
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and…DCK · Traditional | Orion Diagnostica, OY | 03/10/2016SE |
| K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7DCK · Special | Ortho Clinical Diagnostics | 09/24/2015SE |
| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…DCK · Traditional | Qualigen, Inc. | 01/07/2015SE |
| K121558 | Diazyme Hscrp Poc Test KitDCK · Traditional | Diazyme Laboratories | 09/21/2012SE |
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| K980883 | N-Assay Glu-UlCFR · Traditional | 09/03/1998SE |
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| K981289 | N-Assay L T-BilCIG · Traditional | 04/27/1998SE |
| K980902 | N-Assay L Ast/GotCIT · Traditional | 03/26/1998SE |
| K980900 | N-Assay Cpk-LCGS · Traditional | 03/26/1998SE |
| K972257 | N-Assay Tia Antithrombin III Test KitDDQ · Traditional | 10/20/1997SE |
| K971985 | N-Assay Tia Plasminogen Test KitGGP · Traditional | 10/20/1997SE |
| K964296 | N-Assay Tia Apo B Test KitDER · Traditional | 08/01/1997SE |
| K964294 | N-Assay Tia Apo A1/B Multi CalibratorDER · Traditional | 08/01/1997SE |
| K964292 | N-Assay Tia Apo A1 Test KitDER · Traditional | 08/01/1997SE |
Questions and answers
When was N-Assay Tia Multi CRP Calibrator Set cleared by the FDA?
N-Assay Tia Multi CRP Calibrator Set (K965110) received a 510(k) decision of Substantially Equivalent on July 3, 1997, 195 days after the submission was received.
What is the product code of K965110?
The FDA product code is DCK – C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.