FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
K Number: K123930
·
Decision May 15, 2013
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
28
Applicant Total
106
Review Days
146
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Basic Information
- Device Name
- VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
- K Number
- K123930
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1377
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date Received
- December 20, 2012
- Decision Date
- May 15, 2013
- Product Code
- LPS
- 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 |
|---|---|---|---|
| LPS | Urinary Homocystine (Nonquantitative) Test System | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LPS), ordered by most recent decision date.
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