510(k) K964015
K964015 is an FDA 510(k) premarket notification submitted by Litmus Concepts, Inc. for the device "INDICARD TEST". The FDA issued a decision of Substantially Equivalent on June 19, 1997. The device falls under product code MJM (Dna Probe, Gardnerella Vaginalis), a Class I device regulated under 21 CFR 866.2660. Litmus Concepts, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 1997
- Date Received
- October 7, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna Probe, Gardnerella Vaginalis
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type