510(k) K823328
K823328 is an FDA 510(k) premarket notification submitted by Accra Laboratories, Inc. for the device "HARRIS HEMATOXYLIN". The FDA issued a decision of Substantially Equivalent on December 28, 1982. The device falls under product code HYK (Hematoxylin Harris'S), a Class I device regulated under 21 CFR 864.1850. Accra Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1982
- Date Received
- November 8, 1982
- 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