K070174 is an FDA 510(k) clearance for the AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY. This device is classified as a Dna Probe, Nucleic Acid Amplification, Chlamydia (Class I - General Controls, product code MKZ).
Submitted by Roche Diagnostics Corporation (Indianpolis, US). The FDA issued a Cleared decision on April 16, 2007, 88 days after receiving the submission on January 18, 2007.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K070174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2007 |
| Decision Date | April 16, 2007 |
| Days to Decision | 88 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 |