IL TEST HEPARIN— 510(k) K980242
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K980242 for IL TEST HEPARIN, Substantially Equivalent on 1998-03-19. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- 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
- Lexington, MA, US
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More clearances from Instrumentation Laboratory CO
view allRecalls naming K980242
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K980242.
Data sourced from openFDA. This site is unofficial and independent of the FDA.