510(k) K872498
K872498 is an FDA 510(k) premarket notification submitted by Anatech, Ltd. for the device "HARRIS HEMATOXYLIN". The FDA issued a decision of Substantially Equivalent on July 9, 1987. The device falls under product code HYK (Hematoxylin Harris'S), a Class I device regulated under 21 CFR 864.1850. Anatech, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 1987
- Date Received
- June 24, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hematoxylin Harris'S
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type