FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
K Number: K031269
·
Decision May 2, 2003
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
12
Applicant Total
270
Review Days
11
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Basic Information
- Device Name
- ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- K Number
- K031269
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter, Inc.
- Date Received
- April 21, 2003
- Decision Date
- May 2, 2003
- Product Code
- MSW
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| MSW | System, Test, Thyroglobulin | FDA class 2 | Immunology |
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