K934622 is an FDA 510(k) clearance for the LCX CHLAMYDIA TRACHOMATIS ASSAY. This device is classified as a Dna Probe, Nucleic Acid Amplification, Chlamydia (Class I - General Controls, product code MKZ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 8, 1995, 802 days after receiving the submission on September 27, 1993.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K934622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1993 |
| Decision Date | December 08, 1995 |
| Days to Decision | 802 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MKZ — Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3120 |