510(k) K810684
K810684 is an FDA 510(k) premarket notification submitted by Harleco for the device "HEMOCOLOR STAIN SET". The FDA issued a decision of Substantially Equivalent on April 8, 1981. The device falls under product code ICC (Eosin B), a Class I device regulated under 21 CFR 864.1850. Harleco has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1981
- Date Received
- March 13, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Eosin B
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type