510(k) K983774

UALB by Abbott Laboratories — Product Code JIR

K983774 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "UALB". The FDA issued a decision of Substantially Equivalent on January 28, 1999. The device falls under product code JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1645. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1999
Date Received
October 26, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1645
Review Panel
CH
Submission Type