FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74
K Number: K092740
·
Decision Mar 5, 2010
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
63
Applicant Total
883
Review Days
178
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Basic Information
- Device Name
- ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74
- K Number
- K092740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1295
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- September 8, 2009
- Decision Date
- March 5, 2010
- Product Code
- CGN
- 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 |
|---|---|---|---|
| CGN | Acid, Folic, Radioimmunoassay | FDA class 2 | Clinical Chemistry |
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