FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;
K Number: K093611
·
Decision Apr 15, 2010
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
85
Applicant Total
106
Review Days
143
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Basic Information
- Device Name
- VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;
- K Number
- K093611
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date Received
- November 23, 2009
- Decision Date
- April 15, 2010
- Product Code
- KHS
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| KHS | Enzymatic, Carbon-Dioxide | FDA class 2 | Clinical Chemistry |
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VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
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|---|---|---|---|
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| 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 |