510(k) K830964

ANAEROBE MIC/ID TEMPLATE, & TAXONOMY by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JSP

K830964 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "ANAEROBE MIC/ID TEMPLATE, & TAXONOMY". The FDA issued a decision of Substantially Equivalent on May 4, 1983. The device falls under product code JSP (Kit, Anaerobic Identification), 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 4, 1983
Date Received
March 28, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Anaerobic Identification
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type