510(k) K770980
K770980 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "EMATOLOGY DILUENT RESERVOIR CLOSURE". The FDA issued a decision of Substantially Equivalent on July 11, 1977. The device falls under product code GHO (Hemocytometer), a Class I device regulated under 21 CFR 864.6160. 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 11, 1977
- Date Received
- May 31, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemocytometer
- Device Class
- Class I
- Regulation Number
- 864.6160
- Review Panel
- HE
- Submission Type