LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS— 510(k) K850638
Substantially EquivalentBehring Diagnostics, Inc.
FDA 510(k) clearance K850638 for LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS, Substantially Equivalent on 1985-05-15. Applicant: Behring Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Behring Diagnostics, 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
- La Jolla, CA, US
Recent devices under product code MSJ
view all- K072977 — DIAZYME APOLIPOPROTEIN A-1 ASSAY
- K073488 — DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
- K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
- K063608 — DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
- K992662 — 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
More clearances from Behring Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.