Atlas FDA

INFLUENZA A/B RAPID TEST, CAT NO 2158 663

FDA 510(k) clearance K011684 · decided 2001-11-30

Clearance details

K-number
K011684
Device name
INFLUENZA A/B RAPID TEST, CAT NO 2158 663
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2001-05-30
Decision date
2001-11-30
Days to decision
184 days
Clearance type
Traditional
Product code
PSZ
Device class
2
Regulation number
866.3328
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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Elecsys Anti-HBc II (P100031/S033)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc II (P100032/S023)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110031/S027)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110022/S034)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBs (P010054/S048)Roche Diagnostics Corp.2025-05-22
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