ACL TOP MODEL, TOP— 510(k) K033414
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K033414 for ACL TOP MODEL, TOP, Substantially Equivalent on 2004-01-12. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code GKP
- Device class
- Class 2
- Regulation
- 21 CFR 864.5400
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Bedford, MA, US
Recent devices under product code GKP
view all- K242127 — ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
- K231031 — ACL TOP Family 70 Series
- K160276 — ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
- K150877 — ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
- K091980 — ACL TOP 700 LAS
More clearances from Instrumentation Laboratory CO
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