Atlas FDA

HEMOSIL SYNTHASIL

FDA 510(k) clearance K060688 · decided 2006-04-13

Clearance details

K-number
K060688
Device name
HEMOSIL SYNTHASIL
Applicant
Instrumentation Laboratory CO
Decision
Substantially Equivalent
Date received
2006-03-15
Decision date
2006-04-13
Days to decision
29 days
Clearance type
Special
Product code
GFO
Device class
2
Regulation number
864.7925
Medical specialty
Hematology
Advisory committee
Hematology
Location
Bedford, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitu recall (Z-1095-2026)Instrumentation Laboratory2026-01-15