510(k) K892658
K892658 is an FDA 510(k) premarket notification submitted by Scientific Distributors, Inc. for the device "SDI PREPAX COUNTAPETTE KIT". The FDA issued a decision of Substantially Equivalent on May 24, 1989. The device falls under product code JCG (Fluid, Diluting, Manual Cell), a Class I device regulated under 21 CFR 864.8200. Scientific Distributors, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 1989
- Date Received
- April 13, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluid, Diluting, Manual Cell
- Device Class
- Class I
- Regulation Number
- 864.8200
- Review Panel
- HE
- Submission Type