Atlas FDA

ENOXAPARIN TEST CARD

FDA 510(k) clearance K013305 · decided 2002-08-23

Clearance details

K-number
K013305
Device name
ENOXAPARIN TEST CARD
Applicant
Cardiovascular Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2001-10-04
Decision date
2002-08-23
Days to decision
323 days
Clearance type
Traditional
Product code
KFF
Device class
2
Regulation number
864.7525
Medical specialty
Hematology
Advisory committee
Hematology
Location
Morrisville, NC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.