510(k) K934622
K934622 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "LCX CHLAMYDIA TRACHOMATIS ASSAY". The FDA issued a decision of Substantially Equivalent on December 8, 1995. The device falls under product code MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia), a Class I device regulated under 21 CFR 866.3120. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1995
- Date Received
- September 27, 1993
- 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