FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
K Number: K160541
·
Decision Oct 21, 2016
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
31
Review Days
238
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Basic Information
- Device Name
- Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
- K Number
- K160541
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sysmex America, Inc.
- Date Received
- February 26, 2016
- Decision Date
- October 21, 2016
- 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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