FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARCHITECT STAT TROPONIN-I IMMUNOASSAY
K Number: K041192
·
Decision Aug 12, 2004
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
94
Applicant Total
16
Review Days
98
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Basic Information
- Device Name
- ARCHITECT STAT TROPONIN-I IMMUNOASSAY
- K Number
- K041192
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fisher Diagnostics
- Date Received
- May 6, 2004
- Decision Date
- August 12, 2004
- Product Code
- MMI
- 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 |
|---|---|---|---|
| MMI | Immunoassay Method, Troponin Subunit | FDA class 2 | Clinical Chemistry |
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