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Assay, Genotype, Hiv Drug Resistance, In Vitro

Celera Corporation

The following data is part of a premarket notification filed by Celera Corporation with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK130039
510k NumberBK130039
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationAssay, Genotype, Hiv Drug Resistance, In Vitro
Applicant Celera Corporation 1401 Harbor Bay Parkway Alameda,  CA  94502 US
Product CodeNHS  
CFR Regulation Number866.3950 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-08
Decision Date2013-09-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884999039278 BK130039 000

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