Atlas FDA

TAG-IT CYSTIC FIBROSIS KIT

FDA 510(k) clearance DEN050004 · decided 2005-05-09

Clearance details

K-number
DEN050004
Device name
TAG-IT CYSTIC FIBROSIS KIT
Applicant
Tm Bioscience Corporation
Decision
Unknown
Date received
2005-04-05
Decision date
2005-05-09
Days to decision
34 days
Clearance type
Post-NSE
Product code
NUA
Device class
2
Regulation number
866.5900
Medical specialty
Immunology
Advisory committee
Immunology
Location
Toronto, Ontario, CA
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.