510(k) K844571

CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KZJ

K844571 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE". The FDA issued a decision of Substantially Equivalent on January 30, 1985. The device falls under product code KZJ (Device, Gas Generating), a Class I device regulated under 21 CFR 866.2580. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1985
Date Received
November 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Gas Generating
Device Class
Class I
Regulation Number
866.2580
Review Panel
MI
Submission Type