510(k) K842923

PICRIC ACID 1% W/V by E K Ind., Inc. — Product Code LDW

K842923 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "PICRIC ACID 1% W/V". The FDA issued a decision of Substantially Equivalent on September 11, 1984. The device falls under product code LDW (Fixative, Acid Containing), a Class I device regulated under 21 CFR 864.4010. E K Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1984
Date Received
July 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fixative, Acid Containing
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type