510(k) K880549
K880549 is an FDA 510(k) premarket notification submitted by Cytocorp, Inc. for the device "DIACYTE FIXATIVE SOLUTION". The FDA issued a decision of Substantially Equivalent on April 1, 1988. The device falls under product code LDY (Fixative, Formalin-Containing), a Class I device regulated under 21 CFR 864.4010.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 1988
- Date Received
- February 9, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fixative, Formalin-Containing
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type