510(k) K842915

SULFOSALICYLIC ACID, 3% W/V by E K Ind., Inc. — Product Code JIQ

K842915 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "SULFOSALICYLIC ACID, 3% W/V". The FDA issued a decision of Substantially Equivalent on August 10, 1984. The device falls under product code JIQ (Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1645. E K Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1984
Date Received
July 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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