Atlas FDA

OSOM INFLUENZA A&B TEST , MODEL PN190

FDA 510(k) clearance K092633 · decided 2009-09-25

Clearance details

K-number
K092633
Device name
OSOM INFLUENZA A&B TEST , MODEL PN190
Applicant
Genzyme Corporation
Decision
Substantially Equivalent
Date received
2009-08-27
Decision date
2009-09-25
Days to decision
29 days
Clearance type
Special
Product code
PSZ
Device class
2
Regulation number
866.3328
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Cambridge, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.