HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls— 510(k) K170854
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K170854 for HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls, Substantially Equivalent on 2017-09-08. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Product code LCO
- Device class
- Class 2
- Regulation
- 21 CFR 864.7695
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code LCO
view allMore clearances from Instrumentation Laboratory CO
view allRecalls naming K170854
K-number listed on FDA's recall record- Z-0002-2027 — HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
- Z-0001-2027 — HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170854.
Data sourced from openFDA. This site is unofficial and independent of the FDA.