FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
K Number: K992781
·
Decision Apr 5, 2000
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
319
Review Days
230
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Basic Information
- Device Name
- ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
- K Number
- K992781
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio-Rad
- Date Received
- August 19, 1999
- Decision Date
- April 5, 2000
- Product Code
- JJX
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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