510(k) K810040
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