510(k) K842279

BECTEC NR-660 BACTERIAL DETECT SYS by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JTA

K842279 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BECTEC NR-660 BACTERIAL DETECT SYS". The FDA issued a decision of Substantially Equivalent on July 20, 1984. The device falls under product code JTA (Monitor, Microbial Growth), a Class I device regulated under 21 CFR 866.2560. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1984
Date Received
June 8, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Microbial Growth
Device Class
Class I
Regulation Number
866.2560
Review Panel
MI
Submission Type