Atlas FDA

HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES

FDA 510(k) clearance K884590 · decided 1989-01-10

Clearance details

K-number
K884590
Device name
HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES
Applicant
Hemotec, Inc.
Decision
Substantially Equivalent
Date received
1988-11-03
Decision date
1989-01-10
Days to decision
68 days
Clearance type
Traditional
Product code
KFF
Device class
2
Regulation number
864.7525
Medical specialty
Hematology
Advisory committee
Hematology
Location
Englewood, CO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.