510(k) K940979
K940979 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR". The FDA issued a decision of Substantially Equivalent on October 31, 1994. The device falls under product code LSL (Dna-Reagents, Neisseria), a Class II device regulated under 21 CFR 866.3390. Gen-Probe, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1994
- Date Received
- March 1, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna-Reagents, Neisseria
- Device Class
- Class II
- Regulation Number
- 866.3390
- Review Panel
- MI
- Submission Type