HEMOSIL HIGH ABNORMAL CONTROL ASSAYED— 510(k) K021024
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K021024 for HEMOSIL HIGH ABNORMAL CONTROL ASSAYED, Substantially Equivalent on 2002-05-16. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
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More clearances from Instrumentation Laboratory CO
view allRecalls naming K021024
K-number listed on FDA's recall record- Z-0514-2014 — HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
- Z-0515-2014 — HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
- Z-0516-2014 — HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021024.
Data sourced from openFDA. This site is unofficial and independent of the FDA.