Qualitrol CRP Control Set
FDA 510(k) K961829 · Consolidated Technologies, Inc.
510(k) numberK961829
Submission
- Device name
- Qualitrol CRP Control Set
- Applicant
- Consolidated Technologies, Inc.
Austin, TX, US - Received
- May 13, 1996
- Decision date
- August 19, 1996
- 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
Other 510(k)s with product code DCK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242170 | K-ASSAY CRP (Ver.2)DCK · Traditional | Kamiya Biomedical Company, LLC | 04/18/2025SE |
| K201256 | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeDCK · Traditional | Procise Diagnostics | 11/04/2022SE |
| K192028 | Yumizen C1200 CRPDCK · Traditional | Horiba Abx SAS | 06/25/2020SE |
| K192118 | CRP VarioDCK · Special | SENTINEL CH. SpA | 11/08/2019SE |
| K191993 | Yumizen C1200 CRPDCK · Traditional | Horiba Abx SAS | 10/03/2019SE |
| 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 |
More from Diazyme Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K000116 | Qualitrol Urinalysis with Microscopics Control, Levels 1,2 and 3JJY · Traditional | 02/15/2000SE |
| K992578 | Urine Chemistry Control, Level 2JJW · Traditional | 09/03/1999SE |
| K992576 | Urine Chemistry Control, Level 1JJW · Traditional | 09/03/1999SE |
| K992151 | Reference Material for DELTA-9-THC-COOH in Human UrineLAS · Traditional | 07/14/1999SE |
| K981339 | Quickcheck Lyophilized Chemistry Control Conformance Chemistry Control C3JJY · Traditional | 04/21/1998SE |
| K974699 | Reference Material for Amphetamine/Methamphetamine in Human UrineDKB · Traditional | 01/22/1998SE |
| K973469 | Quikcheck Unassayed Chemistry Control Levels 1 and 2, Conformancemccliquichem Unassayed…JJY · Traditional | 09/25/1997SE |
| K972146 | Qualitrol Unassayed H. Pylori Control Set Positive and Negative ControlsLYR · Traditional | 07/08/1997SE |
| K972080 | Qualitrol DHP Immunoassay Control Levels 1,2 and 3, Conformancee Mcc-Ligand Control…JJY · Traditional | 06/18/1997SE |
| K961815 | Qualitrol Ana Control Serum SetLKJ · Traditional | 09/27/1996SE |
Questions and answers
When was Qualitrol CRP Control Set cleared by the FDA?
Qualitrol CRP Control Set (K961829) received a 510(k) decision of Substantially Equivalent on August 19, 1996, 98 days after the submission was received.
What is the product code of K961829?
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.