FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
K Number: K081543
·
Decision Oct 23, 2008
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
106
Review Days
143
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Basic Information
- Device Name
- VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
- K Number
- K081543
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date Received
- June 2, 2008
- Decision Date
- October 23, 2008
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| 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 |