The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Aptima Assay For Chlamydia Trachomatis.
Device ID | K043072 |
510k Number | K043072 |
Device Name: | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS |
Classification | Dna Probe, Nucleic Acid Amplification, Chlamydia |
Applicant | GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego, CA 92121 -4362 |
Contact | Alan Maderazo |
Correspondent | Alan Maderazo GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego, CA 92121 -4362 |
Product Code | MKZ |
CFR Regulation Number | 866.3120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-11-08 |
Decision Date | 2005-01-27 |
Summary: | summary |