Atlas FDA

AB FLU OIA

FDA 510(k) clearance K981651 · decided 1998-11-25

Clearance details

K-number
K981651
Device name
AB FLU OIA
Applicant
Biostar, Inc.
Decision
Substantially Equivalent
Date received
1998-05-11
Decision date
1998-11-25
Days to decision
198 days
Clearance type
Traditional
Product code
PSZ
Device class
2
Regulation number
866.3328
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Boulder, CO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.