510(k) K920225
K920225 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "AUTOSCEPTOR IDENTIFICATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 22, 1992. The device falls under product code LRH (Instrument For Auto Reader Of Overnight Microorganism Identification System), a Class I device regulated under 21 CFR 866.2660. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 1992
- Date Received
- January 17, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument For Auto Reader Of Overnight Microorganism Identification System
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type