510(k) K922588
K922588 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ROCHE ENTEROTUBE II". The FDA issued a decision of Substantially Equivalent on September 11, 1992. The device falls under product code JSS (Kit, Identification, Enterobacteriaceae), a Class I device regulated under 21 CFR 866.2660. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 1992
- Date Received
- June 1, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Identification, Enterobacteriaceae
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type