FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
K Number: K111952
·
Decision Aug 19, 2011
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
244
Applicant Total
270
Review Days
39
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Basic Information
- Device Name
- ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
- K Number
- K111952
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter, Inc.
- Date Received
- July 11, 2011
- Decision Date
- August 19, 2011
- Product Code
- JIT
- 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | FDA class 2 | Clinical Chemistry |
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