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FDA 510(k) Applications Submitted by E JOSEPH MCMULLEN
FDA 510(k) Number
Submission Date
Device Name
Applicant
K062440
08/21/2006
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091
GEN-PROBE, INC.
K981722
05/15/1998
QUIDEL HOME PREGNANCY TEST
QUIDEL CORP.
K003395
11/01/2000
GEN-PROBE APTIMA COMBO 2 ASSAY
GEN-PROBE, INC.
K063451
11/15/2006
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199
GEN-PROBE, INC.
K083430
11/19/2008
REAL-TIME PCR INTERNAL CONTROL 2B SET
NANOGEN, INC.
K063664
12/08/2006
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091
GEN-PROBE, INC.
K974108
10/31/1997
SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)
QUIDEL CORP.
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