510(k) K920225

AUTOSCEPTOR IDENTIFICATION SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LRH

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