Atlas FDA

TAG-IT CYSTIC FIBROSIS KIT

FDA 510(k) clearance K060627 · decided 2006-06-07

Clearance details

K-number
K060627
Device name
TAG-IT CYSTIC FIBROSIS KIT
Applicant
Tm Bioscience Corporation
Decision
Substantially Equivalent
Date received
2006-03-09
Decision date
2006-06-07
Days to decision
90 days
Clearance type
Special
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.