510(k) K822352

HEMATOXYLIN STAIN SOLUTION by Fisher Scientific Co., LLC — Product Code HYJ

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