510(k) K964507
K964507 is an FDA 510(k) premarket notification submitted by Roche Molecular Systems, Inc. for the device "ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST". The FDA issued a decision of Substantially Equivalent on June 13, 1997. The device falls under product code MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia), a Class I device regulated under 21 CFR 866.3120. Roche Molecular Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1997
- Date Received
- November 8, 1996
- 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