FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
K Number: K062123
·
Decision Nov 16, 2006
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
106
Review Days
114
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
- K Number
- K062123
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date Received
- July 25, 2006
- Decision Date
- November 16, 2006
- Product Code
- DIO
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DIO), ordered by most recent decision date.
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DRI Cocaine Metabolite Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DRI Cocaine Metabolite Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Emit II Plus Cocaine Metabolite Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Ortho-Clinical Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Oct 29, 2025 | Substantially Equivalent |
| DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators | May 5, 2023 | Unknown |
| DEN210038 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | May 5, 2023 | Unknown |
| K210858 | VITROS Chemistry Products PHBR Slides | Aug 13, 2021 | Substantially Equivalent |
| K191316 | VITROS XT Chemistry Products ALB-TP Slides | Jun 7, 2019 | Substantially Equivalent |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | Apr 26, 2019 | Substantially Equivalent |
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Apr 3, 2019 | Substantially Equivalent |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | Mar 27, 2019 | Substantially Equivalent |
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Mar 14, 2019 | Substantially Equivalent |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System | Oct 30, 2018 | Substantially Equivalent |