510(k) K810040

ACRIDINE ORANGE STAIN by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code IDC

K810040 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "ACRIDINE ORANGE STAIN". The FDA issued a decision of Substantially Equivalent on February 12, 1981. The device falls under product code IDC (Acridine Orange), a Class I device regulated under 21 CFR 864.1850. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1981
Date Received
January 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acridine Orange
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type