APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS— 510(k) K061377
Substantially EquivalentPointe Scientific, Inc.,
FDA 510(k) clearance K061377 for APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS, Substantially Equivalent on 2007-03-28. Applicant: Pointe Scientific, Inc.,. Device class: 1.
Clearance details
- Applicant
- Pointe Scientific, Inc.,
- Product code
- Code MSJ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincoln Park, MI, US
Recent devices under product code MSJ
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- K992662 — 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
- K970314 — SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
More clearances from Pointe Scientific, Inc.,
view allData sourced from openFDA. This site is unofficial and independent of the FDA.