510(k) K061413
K061413 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM". The FDA issued a decision of Substantially Equivalent on October 13, 2006. The device falls under product code MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia), a Class I device regulated under 21 CFR 866.3120. Gen-Probe, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2006
- Date Received
- May 22, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna Probe, Nucleic Acid Amplification, Chlamydia
- Device Class
- Class I
- Regulation Number
- 866.3120
- Review Panel
- MI
- Submission Type