Atlas FDA

MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER

FDA 510(k) clearance K062751 · decided 2006-10-03

Clearance details

K-number
K062751
Device name
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
Applicant
Quantimetrix Corp.
Decision
Substantially Equivalent
Date received
2006-09-14
Decision date
2006-10-03
Days to decision
19 days
Clearance type
Special
Product code
JJT
Device class
1
Regulation number
862.1660
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Redondo Beach, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.