510(k) K822352
K822352 is an FDA 510(k) premarket notification submitted by Fisher Scientific Co., LLC for the device "HEMATOXYLIN STAIN SOLUTION". The FDA issued a decision of Substantially Equivalent on August 16, 1982. The device falls under product code HYJ (Hematoxylin), a Class I device regulated under 21 CFR 864.1850. Fisher Scientific Co., LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1982
- Date Received
- August 6, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hematoxylin
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type