510(k) K923313
K923313 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ROCHE OXI/FERM II". The FDA issued a decision of Substantially Equivalent on April 5, 1993. The device falls under product code LQM (Gram Negative Identification Panel), 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
- April 5, 1993
- Date Received
- July 7, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gram Negative Identification Panel
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type