510(k) K954933

EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN by Johnson & Johnson Clinical Diagnostics, Inc. — Product Code LDP

K954933 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Clinical Diagnostics, Inc. for the device "EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN". The FDA issued a decision of Substantially Equivalent on December 18, 1995. The device falls under product code LDP (Colorimetry, Acetaminophen), a Class II device regulated under 21 CFR 862.3030. Johnson & Johnson Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1995
Date Received
October 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Acetaminophen
Device Class
Class II
Regulation Number
862.3030
Review Panel
TX
Submission Type