510(k) K943050
K943050 is an FDA 510(k) premarket notification submitted by Dynagen, Inc. for the device "MYCOAKT M KANSASII CULTURE ID KIT". The FDA issued a decision of Substantially Equivalent on March 13, 1995. The device falls under product code JSY (Kit, Identification, Mycobacteria), a Class I device regulated under 21 CFR 866.2660. Dynagen, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1995
- Date Received
- June 27, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Identification, Mycobacteria
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type