510(k) K831090

HEMATOXYLIN GILL FORMULATION IX#56016 by Accra Laboratories, Inc. — Product Code HYJ

K831090 is an FDA 510(k) premarket notification submitted by Accra Laboratories, Inc. for the device "HEMATOXYLIN GILL FORMULATION IX#56016". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code HYJ (Hematoxylin), 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
June 8, 1983
Date Received
April 4, 1983
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