QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)— 510(k) K852418
Substantially EquivalentAmf Biological and Diagnostics Co.
FDA 510(k) clearance K852418 for QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL), Substantially Equivalent on 1985-07-15. Applicant: Amf Biological and Diagnostics Co.. Device class: 1.
Clearance details
- Applicant
- Amf Biological and Diagnostics Co.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seguin, TX, US
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