HEMOLAB HEPARICHROM ASSAY— 510(k) K934274
Substantially EquivalentBiomerieux Vitek, Inc.
FDA 510(k) clearance K934274 for HEMOLAB HEPARICHROM ASSAY, Substantially Equivalent on 1994-05-06. Applicant: Biomerieux Vitek, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomerieux Vitek, Inc.
- Product code
- Product code KFF
- Device class
- Class 2
- Regulation
- 21 CFR 864.7525
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MO, US
Recent devices under product code KFF
view all- K260214 — STA® - Liquid Anti-Xa
- K213464 — HemosIL Liquid Anti-Xa
- K162540 — INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
- K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
- K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
More clearances from Biomerieux Vitek, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.